Clinical trials: Pediatric Disease
Atopic Dermatitis
Long Term Extension Study of Tapinarof Cream, 1% for Subjects With Atopic Dermatitis
This is an open-label, long-term multicenter, study to evaluate the safety and efficacy of topical tapinarof cream, 1% in subjects with atopic dermatitis.
- Trial name
- NCT05142774
- Testing
- Tapinarof cream, 1%
- Where
- 112 sites in United States, Canada
- Volunteers
- 728 people
- Sponsor
- Organon and Co
Systemic Juvenile Idiopathic Arthritis (SJIA)
ß-SPECIFIC 4 Patients: Study of Pediatric EffiCacy and Safety wIth FIrst-line Use of Canakinumab
The purpose of this study was to evaluate the efficacy observed with canakinumab dose reduction in a subgroup of patients in the extension study CACZ885G2301E1.
- Trial name
- ß-SPECIFIC 4 (NCT02296424)
- Testing
- ACZ885 150 mg (Canakinumab)
- Where
- 50 sites in United States, Austria and 14 more
- Volunteers
- 182 people
- Sponsor
- Novartis Pharmaceuticals
Venous Thromboembolism
Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
Three month treatment of acute VTE with Fragmin in pediatric cancer patients
- Trial name
- NCT00952380
- Testing
- dalteparin
- Where
- 26 sites in United States, Norway and 3 more
- Volunteers
- 38 people
- Sponsor
- Pfizer
Leukemia, Lymphoblastic, Acute, Pediatric
Phase II Study of Clofarabine in Pediatric Acute Lymphoblastic Leukemia (ALL)
Clofarabine (injection) is approved by the Food and Drug Administration (FDA) for the treatment of pediatric patients 1 to 21 years old with relapsed acute lymphoblastic leukemia (ALL) who have had at least 2 prior treatment…
- Trial name
- NCT00042341
- Testing
- clofarabine (IV formulation)
- Where
- 14 sites in United States
- Volunteers
- 60 people
- Sponsor
- Genzyme, a Sanofi Company
Progressive Familial Intrahepatic Cholestasis (PFIC)
A Placebo-controlled Study of Maralixibat (SHP625) in Pediatric Subjects With Progressive Familial Intrahepatic Cholestasis (PFIC)
The purpose of this study is to determine if the investigational treatment (maralixibat) is safe and effective in pediatric participants with Progressive Familial Intrahepatic Cholestasis (PFIC).
- Trial name
- NCT03353454
- Testing
- Maralixibat
- Sponsor
- Mirum Pharmaceuticals, Inc.
Influenza
A Surveillance Study of Susceptibility to Baloxavir Marboxil in Pediatric Participants With Influenza and Transmission of Influenza to Household Contacts
This study consists of two parts: Part A Surveillance and Part B Transmission. The main purpose of Part A is to evaluate the prevalence of pre-dose and treatment-emergent amino acid substitutions in pediatric participants' <12…
- Trial name
- Pebblestone (NCT06094010)
- Testing
- Baloxavir Marboxil
- Where
- 51 sites in United States, Bulgaria and 2 more
- Volunteers
- 1,100 people
- Sponsor
- Hoffmann-La Roche
Graft vs Host Disease
Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant
This open-label, single-arm, Phase II multi-center study enrolled 46 participants and investigated the activity, pharmacokinetics and safety of ruxolitinib added to the subject's immunosuppressive regimen among infants, children…
- Trial name
- REACH 5 (NCT03774082)
- Testing
- INC424
- Where
- 21 sites in Brazil, Canada and 12 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
Sickle Cell Disease
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease
The purpose of this study is to determine the correct prasugrel dosage to be given to children with sickle cell disease (SCD).
- Trial name
- Crescent (NCT01476696)
- Testing
- Prasugrel
- Where
- 9 sites in United States
- Volunteers
- 33 people
- Sponsor
- Eli Lilly and Company
Glycogen Storage Disease
A Study of mRNA-3745 in Adult and Pediatric Participants With Glycogen Storage Disease Type 1a (GSD1a)
The main goal of this trial is to evaluate the safety and tolerability of mRNA-3745 via intravenous (IV) administration in adult and pediatric participants with GSD1a.
- Trial name
- NCT05095727
- Testing
- mRNA-3745
- Where
- 16 sites in United States, Canada and 4 more
- Volunteers
- 15 people
- Sponsor
- ModernaTX, Inc.
Pediatric Growth Hormone Deficiency
Versartis Long-Term Safety Study of Somavaratan
Protocol 13VR3 is is a multi-center, open-label study assessing long-term somavaratan administration. Patients will be monitored for safety throughout their participation in the study.
- Trial name
- VISTA (NCT02068521)
- Testing
- somavaratan
- Volunteers
- 385 people
- Sponsor
- Versartis Inc.
Influenza
Safety & Pharmacokinetics Study of Inhaled Laninamivir Octanoate TwinCaps® Dry Powder Inhaler in Children With Influenza
This Phase 1/2 protocol is designed to collect safety, tolerability and pharmacokinetic data of two doses of Laninamivir Octanoate in children and adolescents. The protocol will also explore virology and efficacy endpoints.
- Trial name
- FROSTY (NCT02014649)
- Testing
- 20 mg laninamivir octanoate, 40 mg laninamivir octanoate
- Where
- 28 sites in United States
- Volunteers
- 15 people
- Sponsor
- Biota Scientific Management Pty Ltd
Acute Kidney Injury in Pediatric Patients
Prismaflex HF20 Set and Prismaflex® System 7.10/7.20 for Acute Continuous Renal Replacement Therapy (CRRT) in Children
The primary objective of this study is to evaluate the efficacy of the Gambro Prismaflex® HF20 Set based on testing the hypothesis that it delivers sufficient renal replacement therapy to effectively treat acute kidney injury…
- Trial name
- NCT02561247
- Testing
- Prismaflex HF20 CRRT Filter, Prismaflex® System 7.10 and 7.20
- Where
- 6 sites in United States
- Volunteers
- 23 people
- Sponsor
- Vantive Health LLC
Herpes Simplex
Pharmacokinetics, Acceptability and Safety of Famciclovir in Infants (1 Month to Less Than 12 Months) With Herpes Simplex Infection
This study will evaluate the acceptability and safety of famciclovir in infants with herpes simplex infection
- Trial name
- NCT00448227
- Testing
- famciclovir
- Where
- 6 sites in United States
- Volunteers
- 18 people
- Sponsor
- Novartis
Hepatitis A
Immunogenicity and Safety of Sanofi Pasteur's AVAXIM 80U Pediatric Vaccine Followed by Booster Dose
As per request by the Heath Authorities, the present clinical study will assess the immunogenicity and safety
- Trial name
- NCT00483470
- Testing
- Hepatitis A vaccine AVAXIM 80U, Hepatitis A vaccine (HAVRIX 720)
- Where
- 3 sites in China
- Volunteers
- 720 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Urea Cycle Disorders
Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs)
This non-randomized, open-label study was approximately one year in duration and consisted of a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a 12-month long term treatment period involving…
- Trial name
- NCT01347073
- Testing
- HPN-100
- Where
- 8 sites in United States
- Volunteers
- 23 people
- Sponsor
- Amgen
Immune Thrombocytopenia
Long-term Study of Romiplostim in Thrombocytopenic Pediatric Patients With Immune Thrombocytopenia (ITP)
This is a phase 3b single arm, open label, multicenter study describing the percentage of time pediatric participants with ITP have a platelet response while receiving romiplostim, defined as a platelet count ≥ 50 x 10^9/L in the…
- Trial name
- NCT02279173
- Testing
- Romiplostim
- Where
- 78 sites in United States, Australia and 15 more
- Volunteers
- 203 people
- Sponsor
- Amgen
Crohn's Disease
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical…
- Trial name
- MACARONI-23 (NCT05923073)
- Testing
- Guselkumab
- Where
- 85 sites in United States, Australia and 15 more
- Volunteers
- 120 people
- Sponsor
- Janssen Research & Development, LLC
Central Nervous System Neoplasms, Medulloblastoma
A Study of Pomalidomide Monotherapy for Children and Young Adults With Recurrent or Progressive Primary Brain Tumors
This study will assess the efficacy, safety and tolerability of pomalidomide in children and young adults aged 1 to < 21 years with recurrent or progressive primary brain tumors in one of four primary brain tumor types…
- Trial name
- NCT03257631
- Testing
- Pomalidomide
- Where
- 22 sites in United States, France and 3 more
- Volunteers
- 53 people
- Sponsor
- Celgene
Hearing Loss, Conductive Hearing Loss
Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice.
- Conditions
- Hearing Loss, Conductive Hearing Loss, Atresia
- Trial name
- NCT03723161
- Testing
- Bone Achored Hearing surgery
- Where
- Sweden
- Volunteers
- 15 people
- Sponsor
- Oticon Medical
Diabetes Mellitus, Insulin-Dependent
Comparison of the Ability of Glulisine With Lispro to Control Type 1 Diabetes Mellitus in Children and Adolescents
The purpose of this study is to determine if insulin glulisine (Apidra) is as safe and effective a rapid acting insulin as insulin lispro (Humalog) in children and adolescents with type 1 diabetes mellitus.
- Trial name
- NCT00115570
- Testing
- Insulin glulisine, insulin lispro, insulin glargine
- Where
- United States
- Volunteers
- 572 people
- Sponsor
- Sanofi
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