Clinical trials: Pediatric Safety and Effectiveness
Hypertension
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.
- Trial name
- NCT00756938
- Testing
- losartan potassium
- Volunteers
- 101 people
- Sponsor
- Organon and Co
AML, Childhood, Relapse/Recurrence
Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.
- Conditions
- AML, Childhood, Relapse/Recurrence, Refractory AML, Core Binding Factor Acute Myeloid Leukemia
- Trial name
- NCT06316960
- Testing
- Avapritinib, Azacitidine Injection, Decitabine Injection
- Where
- 12 sites in China
- Volunteers
- 50 people
- Sponsor
- Children's Hospital of Soochow University
Pediatric Recurrent Central Nervous System Tumors
Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Central Nervous System Tumors
The purpose of this research study is to learn about the safety and feasibility of giving a personalized DNA vaccine to people with central nervous system tumors that have returned or have been resistant to treatment.
- Trial name
- NCT03988283
- Testing
- Personalized neoantigen DNA vaccine, Papivax Biotech TDS-IM v2.0, Peripheral blood draw
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- Washington University School of Medicine
Primary Immune Deficiency Disease
Safety and Efficacy Study of Flebogamma 5% DIF IGIV in Pediatric Subjects
This is a multi-center, open-label study to assess the efficacy and safety of Flebogamma 5% DIF in the pediatric population.
- Trial name
- NCT00634569
- Testing
- Flebogamma 5% DIF
- Where
- 7 sites in United States
- Volunteers
- 24 people
- Sponsor
- Instituto Grifols, S.A.
Malaria
Surveillance of Effectiveness/Safety of Artemether-lumefantrine in Patients With Malaria
The purpose of this study is to describe the pediatric and adult patients (U.S. and foreign residents) diagnosed with malaria and treated with artemether-lumefantrine with regard to their demographics, including evaluation of…
- Trial name
- NCT01228344
- Testing
- Artemether-lumefantrine
- Where
- United States
- Volunteers
- 324 people
- Sponsor
- Novartis Pharmaceuticals
Hemodialysis
Efficacy and Safety of Coenzyme Q10 in Pediatric Hemodialysis Patients
All chronic kidney disease patients, whether on regular hemodialysis or not, are at high risk of cardiovascular diseases. This is mainly due to increased oxidative stress, reduced antioxidants and generalized inflammation.
- Trial name
- NCT05170893
- Testing
- Coenzyme Q10
- Where
- Egypt
- Volunteers
- 36 people
- Sponsor
- Ain Shams University
Brain Tumor
Panitumumab-IRDye800 to Detect Pediatric Neoplasms During Neurosurgical Procedures
The objective of the study is to assess safety of panitumumab-IRDye800 in pediatric patients undergoing brain surgery to remove suspected tumors.
- Trial name
- NCT04085887
- Testing
- Panitumumab-IRDye800, Pinpoint-IR9000 endoscopic/handheld device, Explorer Air camera
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Stanford University
HIV
Phase IIIB Study Evaluating the Effects of Atazanavir Powder With Ritonavir in HIV-infected Pediatric Patients
The purpose of this study is to describe the safety, efficacy, and pharmacokinetics of a regimen of atazanavir powder boosted with ritonavir and an optimized dual nucleoside reverse transcriptase inhibitor in pediatric patients…
- Trial name
- PRINCE2 (NCT01335698)
- Testing
- Atazanavir Sulphate, Ritonavir
- Where
- 32 sites in United States, Argentina and 9 more
- Volunteers
- 160 people
- Sponsor
- Bristol-Myers Squibb
Leukodystrophy, Globoid Cell
Study of Safety, Tolerability and Efficacy of PBKR03 in Pediatric Subjects With Early Infantile Krabbe Disease
PBKR03 is a gene therapy for Krabbe Disease (Globoid cell leukodystrophy) intended to deliver a functional copy of the GALC gene to the brain and peripheral tissues.
- Trial name
- GALax-C (NCT04771416)
- Testing
- PBKR03
- Where
- 9 sites in United States, Brazil and 4 more
- Volunteers
- 24 people
- Sponsor
- Gemma Biotherapeutics
Duchenne Muscular Dystrophy (DMD)
A Study to Assess the Safety, Tolerability and Preliminary Efficacy of ASP0367 (MA-0211) in Pediatric Male Participants With Duchenne Muscular Dystrophy (DMD)
The primary purpose of this study is to evaluate the safety and tolerability of ASP0367. This study will also evaluate the pharmacokinetics, pharmacodynamics and efficacy on muscle function of ASP0367.
- Trial name
- NCT04184882
- Testing
- Bocidelpar
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Astellas Pharma Inc
Nasal Congestion
A Nasal Spray for Relief of Nasal Congestion in Infants and Toddlers With Common Cold
The study will evaluate the safety and efficacy of the study medical device plus standard of care versus standard of care in subjects between 3 and 48 months (inclusive) presenting symptoms of a common cold.
- Trial name
- NCT05365789
- Testing
- Blocked Nose Baby nasal spray, Standard of care
- Where
- Poland
- Volunteers
- 220 people, healthy volunteers welcome
- Sponsor
- Church & Dwight Company, Inc.
Migraine, Vascular Headaches
A Study of the Effectiveness and Safety of Topiramate for the Prevention of Migraine Attacks in Children
The primary purpose of this study is to evaluate the effectiveness and safety of topiramate compared with placebo in the prevention of migraine attacks in children (12 to 17 years of age).
- Trial name
- NCT00210535
- Volunteers
- 110 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Glycogen Storage Disease Type II-Pompe's Disease
A Study to Assess Safety and Efficacy of Avalglucosidase Alfa Administered Every Other Week in Pediatric Patients With Infantile-onset Pompe Disease Previously Treated With Alglucosidase Alfa
This is a multi-stage, phase 2, open-label, multicenter, multinational, ascending dose cohort, repeated intravenous (IV) infusion study of avalglucosidase alfa in pediatric patients with Infantile-Onset Pompe Disease (IOPD) who…
- Trial name
- Mini-COMET (NCT03019406)
- Testing
- Avalglucosidase alfa (GZ402666), Alglucosidase alfa (GZ419829)
- Where
- 12 sites in United States, France and 3 more
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Genzyme, a Sanofi Company
Venous Thromboembolism
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
- Trial name
- EINSTEIN Jr (NCT02234843)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- Where
- 109 sites in United States, Argentina and 26 more
- Volunteers
- 500 people
- Sponsor
- Bayer
Acne
Epiduo Pediatric Acne Study
The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.
- Trial name
- NCT01138735
- Testing
- adapalene/benzoyl peroxide, Topical Gel Vehicle
- Where
- 25 sites in United States, Canada
- Volunteers
- 285 people
- Sponsor
- Galderma R&D
Molluscum Contagiosum
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Molluscum Contagiosum
This trial will examine the safety, tolerability and efficacy of one strength of East Indian sandalwood oil (EISO) in a cream base compared to a placebo for treatment of molluscum contagiosum in pediatric subjects.
- Trial name
- NCT02024581
- Testing
- 10% East Indian sandalwood oil cream
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- ViroXis Corporation
Progressive Familial Intrahepatic Cholestasis (PFIC)
An Extension Study of Maralixibat in Patients With Progressive Familial Intrahepatic Cholestasis (PFIC)
The primary objective of this open label extension study is to evaluate the long-term safety and tolerability of maralixibat.
- Trial name
- NCT04185363
- Testing
- Maralixibat
- Where
- 28 sites in United States, Argentina and 14 more
- Volunteers
- 84 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
SCID
JSP191 Antibody Targeting Conditioning in SCID Patients
A Phase 1/2 study to evaluate the safety, tolerability, and efficacy of an antibody conditioning regimen, known as JSP191, in patients with Severe Combined Immune Deficiency undergoing blood stem cell transplantation
- Trial name
- NCT02963064
- Testing
- Humanized anti-CD117 Monoclonal Antibody (JSP191)
- Where
- 9 sites in United States
- Volunteers
- 23 people
- Sponsor
- Jasper Therapeutics, Inc.
Hepatitis C
An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus
The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose…
- Trial name
- NCT01701063
- Testing
- Telaprevir, Peginterferon alfa-2b, Ribavirin
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 42 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Venous Thromboembolism (VTE), Pulmonary Embolism
Hokusai Study in Pediatric Patients With Confirmed Venous Thromboembolism (VTE)
This is an event driven Phase 3, prospective, randomized, open-label, blinded endpoint evaluation (PROBE) parallel group study in subjects with confirmed VTE.
- Conditions
- Venous Thromboembolism (VTE), Pulmonary Embolism, Deep Vein Thrombosis (DVT)
- Trial name
- NCT02798471
- Testing
- Edoxaban, Standard of Care
- Where
- 140 sites in United States, Argentina and 32 more
- Volunteers
- 290 people
- Sponsor
- Daiichi Sankyo
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