Clinical trials: Disorder, Pediatric
Duchenne Muscular Dystrophy
An Open-Label Extension Study of Edasalonexent in Boys With Duchenne Muscular Dystrophy
The GalaxyDMD study is a global Phase 3, open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of edasalonexent in pediatric patients with a genetically confirmed…
- Trial name
- GalaxyDMD (NCT03917719)
- Testing
- Edasalonexent
- Where
- 23 sites in United States, Australia and 4 more
- Volunteers
- 130 people
- Sponsor
- Catabasis Pharmaceuticals
SARS-CoV Infection, Covid19
A Study to Evaluate the Efficacy, Immune Response, and Safety of a COVID-19 Vaccine in Adults ≥ 18 Years With a Pediatric Expansion in Adolescents (12 to<18 Years) at Risk for SARS-CoV-2
This is a phase 3, randomized, observer-blinded, placebo-controlled study to evaluate the efficacy, safety, and immunogenicity of SARS-CoV-2 rS with Matrix-M1 adjuvant in adult participants and adolescent participants.
- Trial name
- NCT04611802
- Testing
- SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period), SARS-CoV-2 rS/Matrix-M1 Adjuvant (Booster Vaccination)
- Where
- 154 sites in United States, Mexico and 1 more
- Volunteers
- 33,000 people, healthy volunteers welcome
- Sponsor
- Novavax
Severe Hemophilia A
Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia A
This study was divided into four stages: screening period, main trial period, extension period and follow-up period. In the main trial, both groups received FRSW107 prophylactic therapy.
- Trial name
- NCT06136507
- Testing
- FRSW107
- Where
- 13 sites in China
- Volunteers
- 76 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Infantile Colic
Lactobacillus Reuteri Supplementation in the Treatment of Infantile Colic
The purpose of this study is to evaluate the efficacy of the oral administration of Lactobacillus reuteri in treating infantile colic as defined by the Rome III criteria.
- Trial name
- PROBIOC (NCT01887444)
- Testing
- Lactobacillus reuteri DSM17938 probiotic
- Where
- France
- Sponsor
- BioGaia AB
Growth Hormone Deficiency, Pediatric, Endocrine System Diseases
A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency
A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (GHD) will be included.
- Conditions
- Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases
- Trial name
- NCT03305016
- Testing
- TransCon hGH
- Where
- 24 sites in United States, Australia and 2 more
- Volunteers
- 146 people
- Sponsor
- Ascendis Pharma Endocrinology Division A/S
Type 2 Diabetes Mellitus
PK Study of Dapagliflozin in Pediatric Subjects With T2DM
The primary purpose of this study is to evaluate the pharmacokinetics (PK) of Dapagliflozin in pediatric subjects with type 2 diabetes mellitus (T2DM)
- Trial name
- NCT01525238
- Testing
- Dapagliflozin
- Where
- 17 sites in United States, Mexico
- Volunteers
- 53 people
- Sponsor
- AstraZeneca
Pulmonary Arterial Hypertension
Effects of Two Dosing Regimens of Bosentan in Children With Pulmonary Arterial Hypertension
The primary objective of AC-052-373 was to assess the pharmacokinetic (PK) profile of two dosing regimens of the pediatric formulation of bosentan in children with pulmonary arterial hypertension (PAH) <12 years of age.
- Trial name
- FUTURE 3 (NCT01223352)
- Testing
- bosentan
- Volunteers
- 64 people
- Sponsor
- Actelion
Niemann-Pick Disease, Type C
Safety and Tolerability Study of VTS-270 in Pediatric Participants With Niemann-Pick Type C (NPC) Disease
This is a Phase-2, multicenter, multiple dose, open-label, 2-part evaluation study which will primarily assess the safety and tolerability of VTS-270 (2-hydroxypropyl beta-cyclodextrin [HP-β-CD]) in pediatric participants with…
- Trial name
- NCT03687476
- Testing
- VTS-270
- Sponsor
- Vtesse, LLC, a Mallinckrodt Pharmaceuticals Company
Hypertension
Atacand Dose Ranging in Hypertensive Pediatric Subjects 1 Year to Less Than 6 Years of Age
This is a dose ranging study of candesartan cilexetil in hypertensive pediatric subjects ages 1 to less than 6 years of age. It employs a double blind, randomized, dose ranging design intended for conduct as a multicenter trial.
- Trial name
- NCT00244621
- Testing
- candesartan cilexetil (Atacand)
- Where
- 38 sites in United States, Belgium and 8 more
- Volunteers
- 95 people
- Sponsor
- AstraZeneca
Asthma
Nebulized Magnesium Sulfate in Children With Moderate to Severe Asthma
The purpose of this study is to investigate the use of magnesium sulfate nebulization in patient with moderate to severe asthma exacerbation in pediatric emergency.
- Trial name
- NCT01584726
- Testing
- Magnesium Sulfate
- Where
- 2 sites in Qatar
- Volunteers
- 400 people
- Sponsor
- Hamad Medical Corporation
Malaria, Vivax
An Interventional Study to Compare the Efficacy and Safety of Tafenoquine (TQ) and Primaquine (PQ) When Either Are Taken Together With Chloroquine (CQ) for the Treatment of P. Vivax Malaria in Indian Participants Aged 2 Years and Older
The aim of this study is to collect efficacy and safety data to support the registration of tafenoquine in India.
- Trial name
- NCT06666491
- Testing
- Tafenoquine, Primaquine, Chloroquine
- Where
- 5 sites in India
- Volunteers
- 324 people
- Sponsor
- GlaxoSmithKline
Hypercortisolism, Cushing Syndrome
Retrospective Chart Review Study of Pediatric Patients Treated With Korlym for Cushing Syndrome
This retrospective, multi-center, chart review study will collect patient data from medical charts of pediatric patients who have been treated with Korlym for Cushing's syndrome.
- Trial name
- NCT03379363
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Corcept Therapeutics
Leukemia
A Phase 1 Dose-escalation Study to Evaluate the Safety and Pharmacokinetics (PK) of Palifermin in Subjects With Acute Leukemias Undergoing HSCT
20010133 is an open-label, dose escalation study in pediatric patients with acute leukemias receiving myelotoxic therapy (high dose etoposide, cyclophosphamide and total body irradiation [TBI]) followed by hematopoietic stem cell…
- Trial name
- NCT00460421
- Testing
- Palifermin, Total Body irradiation, Chemotherapy
- Where
- 7 sites in United States
- Volunteers
- 27 people
- Sponsor
- Swedish Orphan Biovitrum
Pneumonia, Pneumocystis Carinii, HIV Infections
A Study of Trimetrexate Plus Leucovorin in Children With Pneumocystis Carinii Pneumonia
To evaluate the safety and efficacy of trimetrexate glucuronate with leucovorin protection in pediatric patients with Pneumocystis carinii pneumonia (PCP) who are refractory to or have demonstrated severe or life-threatening…
- Trial name
- NCT00002317
- Testing
- Trimetrexate glucuronate, Leucovorin calcium
- Where
- United States
- Sponsor
- U.S. Bioscience
Hepatitis C, Chronic
Study of PEG-Intron Plus REBETOL in Pediatric Subjects With Chronic Hepatitis C (Study P02538 Part 1)
The primary objective is to assess the safety, efficacy and tolerability of the combination of PEG-Intron plus REBETOL in pediatric subjects with chronic hepatitis C.
- Trial name
- NCT00104052
- Testing
- peginterferon alfa-2b (PEG2b) (SCH 54031), ribavirin (SCH 18908)
- Volunteers
- 107 people
- Sponsor
- Merck Sharp & Dohme LLC
Hemophilia A
Study of Pharmacokinetics, Efficacy, and Safety of a Recombinant and Protein-Free Factor VIII (rAHF-PFM) in Pediatric Patients With Hemophilia A
The purpose of this study is to evaluate whether rAHF-PFM is effective and safe in the treatment of children with hemophilia A. The study consists of 2 parts.
- Trial name
- NCT00157040
- Testing
- Antihemophilic factor, recombinant, manufactured protein-free
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 50 people
- Sponsor
- Baxalta now part of Shire
Idiopathic Thrombocytopenic Purpura, Thrombocytopenia
Safety and Efficacy Study of Romiplostim to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients
The purpose of this study is to evaluate the efficacy of romiplostim in the treatment of thrombocytopenia in pediatric patients with Immune thrombocytopenia purpura (ITP) as measured by durable platelet response.
- Conditions
- Idiopathic Thrombocytopenic Purpura, Thrombocytopenia, Thrombocytopenia in Pediatric Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP), Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
- Trial name
- NCT01444417
- Testing
- Romiplostim
- Where
- 33 sites in United States, Australia and 1 more
- Volunteers
- 62 people
- Sponsor
- Amgen
Heart Defects, Congenital
Safety and Performance of the COR-VG-001 Conduit in Pediatric Patients for Extracardiac Total Cavopulmonary Connection
The extracardiac Fontan surgery/procedure involves diverting the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle.
- Trial name
- EC-TCPC (NCT02377674)
- Testing
- Vascular Graft, Model COR-VG-001
- Where
- Russia
- Volunteers
- 5 people
- Sponsor
- Xeltis
Hepatitis B
A Real-World Observational Study for the Safety and Efficacy of Baraclude in Korean Pediatric Patients With Chronic Hepatitis B
This is a local, prospective observational study (regulatory post marketing surveillance) to access the safety and effectiveness of Baraclude in Korean pediatric patients with chronic HBV infection who are between the ages of 2…
- Trial name
- NCT03426618
- Testing
- Non-interventional
- Where
- South Korea
- Volunteers
- 1 people
- Sponsor
- Bristol-Myers Squibb
Esophagitis
Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years
The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive…
- Trial name
- NCT04821310
- Where
- 27 sites in United States, Bosnia and Herzegovina and 7 more
- Volunteers
- 43 people
- Sponsor
- Pfizer
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