Finpedmed
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Public Notifications of the Service Requests

FINPEDMED aims to increase public awareness about the important progress in increasing pediatric drug development and pediatric clinical trials in Finland (and in Europe). This can be promoted by publishing some basic information of the Service Requests submitted to FINPEDMED. Service Requests are preliminary inquires of possible new trials addressed to the FINPEDMED investigators, who evaluate whether these could be conducted also in Finland.

FINPEDMED Service Request´s public information is listed on a table below. You may open each request and look for the details by clicking the bar arrow beside the number. Service Request category C includes Consultations (i.e. Expert Board Services) and category R includes Basic feasibility assessment for a new clinical trial.

# R3561-113 Opioid induced constipation
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Oncology
2. Medical condition or disease Opioid induced constipation
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Spring 2014
11. Completion date depending on the use of opioids
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-125 Epilepsy
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neurology
2. Medical condition or disease Epilepsy
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date November 2014
11. Completion date November 2014
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# C3561-33
Service Request status Completed
# R3561-126 pediatric type 2 diabetes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease pediatric type 2 diabetes
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date already started
11. Completion date Aug-2015
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-127 B-precursor ALL
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
2. Medical condition or disease B-precursor ALL
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Feb2015
11. Completion date Feb2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-129 euvolemic or hypervolemic hyponatremia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Other – not classified
2. Medical condition or disease euvolemic or hypervolemic hyponatremia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 18th August (first patient in US), December 2014 in Finland
11. Completion date 31rst March 2017 (last patient last visit)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-34
Service Request status Completed
# C3561-35
Service Request status Completed
# C3561-36
Service Request status Completed
# R3561-130 Prevention of Chemotherapy-Induced Nausea and Vomiting
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Oncology
2. Medical condition or disease Prevention of Chemotherapy-Induced Nausea and Vomiting
8. Patients / study subjects: Age group / groups b. Term newborn infants; 0-27 days
c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date May-2015
11. Completion date June-2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-131 neutropenia or expected neutropenia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
Infectious diseases
Oncology
Paediatric Intensive Care
Transplantation
2. Medical condition or disease neutropenia or expected neutropenia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 24-Jun-2015 First subject entered
11. Completion date 26-Apr-2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-132 Heterozygous Familiar Hypercholesterolemia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
2. Medical condition or disease Heterozygous Familiar Hypercholesterolemia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 6/2015
11. Completion date 9/2016
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-133 Atopic Dermatitis
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Dermatology
2. Medical condition or disease Atopic Dermatitis
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Q1-2015
11. Completion date Q3-2016
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-136 MDD
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Adolescent Psychiatry
Child Psychiatry
2. Medical condition or disease MDD
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Jan-2016
11. Completion date na
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-37 Type 1 Diabetes Mellitus
Service Request status Completed
2. Medical condition or disease Type 1 Diabetes Mellitus
# R3561-137 Pediatric Treatment of VTE with rivaroxaban
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
2. Medical condition or disease Pediatric Treatment of VTE with rivaroxaban
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
10. Start date Jan 2015
11. Completion date Mar 2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-138 Pediatric Treatment of VTE with rivaroxaban
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
2. Medical condition or disease Pediatric Treatment of VTE with rivaroxaban
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Nov 2014
11. Completion date Nov 2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# C3561-39 Single-dose study of oral rivaroxaban dry powder suspension formulation in children treated for thrombosis
Service Request status Completed
2. Medical condition or disease Single-dose study of oral rivaroxaban dry powder suspension formulation in children treated for thrombosis
# R3561-139 Repeated seizures
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neonatology
Neurology
2. Medical condition or disease Repeated seizures
8. Patients / study subjects: Age group / groups a. Preterm newborn infants (gestational age <37 weeks)
b. Term newborn infants; 0-27 days
10. Start date tbc
11. Completion date tbc
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-40 Paediatric Melanoma / Lymphoma
Service Request status Completed
2. Medical condition or disease Paediatric Melanoma / Lymphoma
# C3561-41 Children with persistent asthma
Service Request status Completed
2. Medical condition or disease Children with persistent asthma
# R3561-140 Intravascular Procedures For Congenital Heart Disease
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
Surgery
2. Medical condition or disease Intravascular Procedures For Congenital Heart Disease
8. Patients / study subjects: Age group / groups b. Term newborn infants; 0-27 days
c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date not known at this stage
11. Completion date not known at this stage
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-141 Diebetes Mellitus type 1
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Diebetes Mellitus type 1
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Q3 2015 (FPI)
11. Completion date Q3 2017 (LPLV)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-142 Persistent asthma on ICS/LABA treatment
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Allergology
2. Medical condition or disease Persistent asthma on ICS/LABA treatment
8. Patients / study subjects: Age group / groups N/A
10. Start date 5 / 2016
11. Completion date Last patient last visit 1 / 2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-42 MDD (major depression disorder)
Service Request status Completed
2. Medical condition or disease MDD (major depression disorder)
# R3561-143 secondary thrombocytopenia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
Oncology
2. Medical condition or disease secondary thrombocytopenia
8. Patients / study subjects: Age group / groups N/A
10. Start date 2015
11. Completion date 2019
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-43 Juvenile idiopathic arthritis
Service Request status Completed
2. Medical condition or disease Juvenile idiopathic arthritis
# R3561-146 Major Depressive Disorder (MDD)
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Adolescent Psychiatry
Child Psychiatry
2. Medical condition or disease Major Depressive Disorder (MDD)
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date FPI 01Mar2016 (screened)
11. Completion date Enrolment 28 months
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-44 Crohn´s disease
Service Request status Completed
2. Medical condition or disease Crohn´s disease
# C3561-45 prohlylaxis of thrombotic complications in children born with a single ventricle
Service Request status Completed
2. Medical condition or disease prohlylaxis of thrombotic complications in children born with a single ventricle
# R3561-147 venous thromboembolism
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
2. Medical condition or disease venous thromboembolism
8. Patients / study subjects: Age group / groups b. Term newborn infants; 0-27 days
c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Q2 2016
11. Completion date TBD
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-148 Type 2 diabetes mellitus 10 -17 years old
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Type 2 diabetes mellitus 10 -17 years old
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date Estimation: Study to be started 2-3 Q2016
11. Completion date Estimation 2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-149 recurrent pediatric clostridium difficile infections
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Infectious diseases
2. Medical condition or disease recurrent pediatric clostridium difficile infections
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date TBD
11. Completion date TBD
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-150 Glucocorticoid induced Osteoporisis
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Other – not classified
2. Medical condition or disease Glucocorticoid induced Osteoporisis
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Dec 2016
11. Completion date Dec 2021 (enrolment ending: Dec 2018)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-151 Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Dermatology
Infectious diseases
2. Medical condition or disease Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
8. Patients / study subjects: Age group / groups d. Children 2-11 years
10. Start date 01/2017
11. Completion date 02/2019
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-152 Pulmonary Arterial Hypertension (PAH)
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
2. Medical condition or disease Pulmonary Arterial Hypertension (PAH)
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 2016
11. Completion date 2020
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-46 Cystic Fibrosis
Service Request status Completed
2. Medical condition or disease Cystic Fibrosis
# R3561-153 Psoriatic and enthesitis-related arthritis JIA subtypes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Rheumatology
2. Medical condition or disease Psoriatic and enthesitis-related arthritis JIA subtypes
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date March 2017
11. Completion date November 2020
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-154 Respiratory Syncytial Virus
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Infectious diseases
2. Medical condition or disease Respiratory Syncytial Virus
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
10. Start date Oct2016
11. Completion date Jul2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-155 Type II Diabetes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Type II Diabetes
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date 01Mar2017
11. Completion date 31Jan2022
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-156 Pediatric Atopic Dermatitis
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Allergology
Dermatology
Immunology
2. Medical condition or disease Pediatric Atopic Dermatitis
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
10. Start date Part A: Dec 2016 Part B: Dec 2016
11. Completion date Part A: Mar 2018 Part B: Mar 2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-47 Cystic Fibrosis
Service Request status Completed
2. Medical condition or disease Cystic Fibrosis
# C3561-48 severe ulcerative colitis (US) or Crohn’s disease (CD).
Service Request status Completed
2. Medical condition or disease severe ulcerative colitis (US) or Crohn’s disease (CD).
# C3561-49 heterozygous familial hypercholesterolemia (children and adolescents)
Service Request status Completed
2. Medical condition or disease heterozygous familial hypercholesterolemia (children and adolescents)
# R3561-157 Type 2 diabetes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Type 2 diabetes
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date 19Apr2017
11. Completion date 31Dec2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-159 Homozygous familial hypersholesterolemia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Homozygous familial hypersholesterolemia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date May 2018
11. Completion date June 2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# C3561-50 Type 1 spinal muscular atrophy
Service Request status Completed
2. Medical condition or disease Type 1 spinal muscular atrophy
# R3561-160 SMA (Spinal Muscular Atrophy) TYPE 2 and TYPE 3
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neurology
2. Medical condition or disease SMA (Spinal Muscular Atrophy) TYPE 2 and TYPE 3
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date FPFV JUNE 2018
11. Completion date LPLV APR 2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No

Public Notifications of the Service Requests

FINPEDMED aims to increase public awareness about the important progress in increasing pediatric drug development and pediatric clinical trials in Finland (and in Europe). This can be promoted by publishing some basic information of the Service Requests submitted to FINPEDMED. Service Requests are preliminary inquires of possible new trials addressed to the FINPEDMED investigators, who evaluate whether these could be conducted also in Finland.

FINPEDMED Service Request´s public information is listed on a table below. You may open each request and look for the details by clicking the bar arrow beside the number. Service Request category C includes Consultations (i.e. Expert Board Services) and category R includes Basic feasibility assessment for a new clinical trial.

# R3561-113 Opioid induced constipation
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Oncology
2. Medical condition or disease Opioid induced constipation
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Spring 2014
11. Completion date depending on the use of opioids
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-125 Epilepsy
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neurology
2. Medical condition or disease Epilepsy
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date November 2014
11. Completion date November 2014
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# C3561-33
Service Request status Completed
# R3561-126 pediatric type 2 diabetes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease pediatric type 2 diabetes
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date already started
11. Completion date Aug-2015
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-127 B-precursor ALL
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
2. Medical condition or disease B-precursor ALL
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Feb2015
11. Completion date Feb2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-129 euvolemic or hypervolemic hyponatremia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Other – not classified
2. Medical condition or disease euvolemic or hypervolemic hyponatremia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 18th August (first patient in US), December 2014 in Finland
11. Completion date 31rst March 2017 (last patient last visit)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-34
Service Request status Completed
# C3561-35
Service Request status Completed
# C3561-36
Service Request status Completed
# R3561-130 Prevention of Chemotherapy-Induced Nausea and Vomiting
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Oncology
2. Medical condition or disease Prevention of Chemotherapy-Induced Nausea and Vomiting
8. Patients / study subjects: Age group / groups b. Term newborn infants; 0-27 days
c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date May-2015
11. Completion date June-2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-131 neutropenia or expected neutropenia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
Infectious diseases
Oncology
Paediatric Intensive Care
Transplantation
2. Medical condition or disease neutropenia or expected neutropenia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 24-Jun-2015 First subject entered
11. Completion date 26-Apr-2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-132 Heterozygous Familiar Hypercholesterolemia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
2. Medical condition or disease Heterozygous Familiar Hypercholesterolemia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 6/2015
11. Completion date 9/2016
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-133 Atopic Dermatitis
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Dermatology
2. Medical condition or disease Atopic Dermatitis
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Q1-2015
11. Completion date Q3-2016
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-136 MDD
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Adolescent Psychiatry
Child Psychiatry
2. Medical condition or disease MDD
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Jan-2016
11. Completion date na
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-37 Type 1 Diabetes Mellitus
Service Request status Completed
2. Medical condition or disease Type 1 Diabetes Mellitus
# R3561-137 Pediatric Treatment of VTE with rivaroxaban
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
2. Medical condition or disease Pediatric Treatment of VTE with rivaroxaban
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
10. Start date Jan 2015
11. Completion date Mar 2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-138 Pediatric Treatment of VTE with rivaroxaban
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
2. Medical condition or disease Pediatric Treatment of VTE with rivaroxaban
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Nov 2014
11. Completion date Nov 2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# C3561-39 Single-dose study of oral rivaroxaban dry powder suspension formulation in children treated for thrombosis
Service Request status Completed
2. Medical condition or disease Single-dose study of oral rivaroxaban dry powder suspension formulation in children treated for thrombosis
# R3561-139 Repeated seizures
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neonatology
Neurology
2. Medical condition or disease Repeated seizures
8. Patients / study subjects: Age group / groups a. Preterm newborn infants (gestational age <37 weeks)
b. Term newborn infants; 0-27 days
10. Start date tbc
11. Completion date tbc
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-40 Paediatric Melanoma / Lymphoma
Service Request status Completed
2. Medical condition or disease Paediatric Melanoma / Lymphoma
# C3561-41 Children with persistent asthma
Service Request status Completed
2. Medical condition or disease Children with persistent asthma
# R3561-140 Intravascular Procedures For Congenital Heart Disease
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
Surgery
2. Medical condition or disease Intravascular Procedures For Congenital Heart Disease
8. Patients / study subjects: Age group / groups b. Term newborn infants; 0-27 days
c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date not known at this stage
11. Completion date not known at this stage
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-141 Diebetes Mellitus type 1
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Diebetes Mellitus type 1
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Q3 2015 (FPI)
11. Completion date Q3 2017 (LPLV)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-142 Persistent asthma on ICS/LABA treatment
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Allergology
2. Medical condition or disease Persistent asthma on ICS/LABA treatment
8. Patients / study subjects: Age group / groups N/A
10. Start date 5 / 2016
11. Completion date Last patient last visit 1 / 2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-42 MDD (major depression disorder)
Service Request status Completed
2. Medical condition or disease MDD (major depression disorder)
# R3561-143 secondary thrombocytopenia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Haematology
Oncology
2. Medical condition or disease secondary thrombocytopenia
8. Patients / study subjects: Age group / groups N/A
10. Start date 2015
11. Completion date 2019
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-43 Juvenile idiopathic arthritis
Service Request status Completed
2. Medical condition or disease Juvenile idiopathic arthritis
# R3561-146 Major Depressive Disorder (MDD)
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Adolescent Psychiatry
Child Psychiatry
2. Medical condition or disease Major Depressive Disorder (MDD)
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date FPI 01Mar2016 (screened)
11. Completion date Enrolment 28 months
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-44 Crohn´s disease
Service Request status Completed
2. Medical condition or disease Crohn´s disease
# C3561-45 prohlylaxis of thrombotic complications in children born with a single ventricle
Service Request status Completed
2. Medical condition or disease prohlylaxis of thrombotic complications in children born with a single ventricle
# R3561-147 venous thromboembolism
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
2. Medical condition or disease venous thromboembolism
8. Patients / study subjects: Age group / groups b. Term newborn infants; 0-27 days
c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Q2 2016
11. Completion date TBD
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-148 Type 2 diabetes mellitus 10 -17 years old
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Type 2 diabetes mellitus 10 -17 years old
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date Estimation: Study to be started 2-3 Q2016
11. Completion date Estimation 2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-149 recurrent pediatric clostridium difficile infections
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Infectious diseases
2. Medical condition or disease recurrent pediatric clostridium difficile infections
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date TBD
11. Completion date TBD
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-150 Glucocorticoid induced Osteoporisis
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Other – not classified
2. Medical condition or disease Glucocorticoid induced Osteoporisis
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date Dec 2016
11. Completion date Dec 2021 (enrolment ending: Dec 2018)
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-151 Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Dermatology
Infectious diseases
2. Medical condition or disease Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
8. Patients / study subjects: Age group / groups d. Children 2-11 years
10. Start date 01/2017
11. Completion date 02/2019
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# R3561-152 Pulmonary Arterial Hypertension (PAH)
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Cardiovascular diseases
2. Medical condition or disease Pulmonary Arterial Hypertension (PAH)
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date 2016
11. Completion date 2020
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# C3561-46 Cystic Fibrosis
Service Request status Completed
2. Medical condition or disease Cystic Fibrosis
# R3561-153 Psoriatic and enthesitis-related arthritis JIA subtypes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Rheumatology
2. Medical condition or disease Psoriatic and enthesitis-related arthritis JIA subtypes
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date March 2017
11. Completion date November 2020
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-154 Respiratory Syncytial Virus
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Infectious diseases
2. Medical condition or disease Respiratory Syncytial Virus
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
10. Start date Oct2016
11. Completion date Jul2017
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# R3561-155 Type II Diabetes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Type II Diabetes
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date 01Mar2017
11. Completion date 31Jan2022
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-156 Pediatric Atopic Dermatitis
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Allergology
Dermatology
Immunology
2. Medical condition or disease Pediatric Atopic Dermatitis
8. Patients / study subjects: Age group / groups c. Infant and toddler; 28 days-23 months
d. Children 2-11 years
10. Start date Part A: Dec 2016 Part B: Dec 2016
11. Completion date Part A: Mar 2018 Part B: Mar 2018
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) N/A
# C3561-47 Cystic Fibrosis
Service Request status Completed
2. Medical condition or disease Cystic Fibrosis
# C3561-48 severe ulcerative colitis (US) or Crohn’s disease (CD).
Service Request status Completed
2. Medical condition or disease severe ulcerative colitis (US) or Crohn’s disease (CD).
# C3561-49 heterozygous familial hypercholesterolemia (children and adolescents)
Service Request status Completed
2. Medical condition or disease heterozygous familial hypercholesterolemia (children and adolescents)
# R3561-157 Type 2 diabetes
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Type 2 diabetes
8. Patients / study subjects: Age group / groups e. Adolescents 12-17 years (under 18 years)
10. Start date 19Apr2017
11. Completion date 31Dec2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) Yes
# R3561-159 Homozygous familial hypersholesterolemia
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Endocrinology
2. Medical condition or disease Homozygous familial hypersholesterolemia
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date May 2018
11. Completion date June 2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No
# C3561-50 Type 1 spinal muscular atrophy
Service Request status Completed
2. Medical condition or disease Type 1 spinal muscular atrophy
# R3561-160 SMA (Spinal Muscular Atrophy) TYPE 2 and TYPE 3
Service Request status Completed
1. Pediatric therapeutic area OR specialty / subspecialty (-ies) Neurology
2. Medical condition or disease SMA (Spinal Muscular Atrophy) TYPE 2 and TYPE 3
8. Patients / study subjects: Age group / groups d. Children 2-11 years
e. Adolescents 12-17 years (under 18 years)
10. Start date FPFV JUNE 2018
11. Completion date LPLV APR 2021
34. Trial protocol is part of the accepted PIP (Pediatric Investigation Plan) by the EMA PDCO (European Medicines Agency, Pediatric Committee) No