Clinical trials: Pediatric Disease
Urinary Tract Infections
A Study in Pediatric Participants Aged ≥2 to <12 Years With a Suspected or Confirmed Bacterial Infection or Receiving Prophylaxis Antibiotics
The study will be conducted to evaluate how a single oral dose of Gepotidacin is processed in the body over time along with safety monitoring in hospitalized pediatric participants who are receiving a standard of care treatment…
- Trial name
- NCT07371429
- Testing
- Gepotidacin, SOC
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- GlaxoSmithKline
Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or Tetrahydrobiopterin (BH4) Deficiency
Observational Study on the Long Term Safety of Kuvan® Treatment in Patients With Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or BH4 Deficiency
Kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (BH4). BH4 is required by the body to use an amino acid called phenylalanine in order to build another substance called tyrosine.
- Trial name
- KAMPER (NCT01016392)
- Where
- 69 sites in Austria, France and 7 more
- Volunteers
- 627 people
- Sponsor
- BioMarin Pharmaceutical
Relapsing-remitting Multiple Sclerosis
A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)
This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with RRMS aged between 10 and < 18 years over a flexible duration.
- Trial name
- Operetta 2 (NCT05123703)
- Testing
- Ocrelizumab, Fingolimod
- Where
- 71 sites in United States, Argentina and 23 more
- Volunteers
- 188 people
- Sponsor
- Hoffmann-La Roche
Asthma
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.
- Trial name
- NCT00943683
- Testing
- montelukast sodium
- Volunteers
- 256 people
- Sponsor
- Organon and Co
Venous Thromboembolism
EINSTEIN Junior Phase II: Oral Rivaroxaban in Young Children With Venous Thrombosis
The purpose of this study is to find out whether rivaroxaban is safe to use in children and how long it stays in the body. Safety will be assessed by looking at the incidence and types of bleeding events.
- Trial name
- EINSTEINJr (NCT02309411)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 29 sites in United States, Australia and 13 more
- Volunteers
- 46 people
- Sponsor
- Bayer
Urinary Incontinence
Study of OnabotulinumtoxinA (BOTOX®) for Urinary Incontinence Due to Neurogenic Detrusor Overactivity in Pediatric Patients
This study will evaluate the 3 doses of onabotulinumtoxinA (botulinum toxin Type A) for the treatment of urinary incontinence due to neurogenic detrusor overactivity in pediatric participants between the ages of 5 to 17 years to…
- Trial name
- NCT01852045
- Testing
- OnabotulinumtoxinA
- Where
- 31 sites in United States, Belgium and 6 more
- Volunteers
- 114 people
- Sponsor
- Allergan
Hemophilia A
GAS-Hem Feasibility Study
The purpose of this study is to investigate the feasibility and acceptability of the Standardized Goal Attainment Scaling menu for Hemophilia (GAS-Hem) as a patient reported outcome (PRO) measure to monitor clinical progress in…
- Trial name
- NCT02674997
- Testing
- Factor VIII
- Where
- 4 sites in United States, Canada
- Volunteers
- 44 people
- Sponsor
- Baxalta now part of Shire
Hyperphosphatemia Related to Chronic Kidney Disease
Study to Evaluate the Safety and Tolerability of Ferric Citrate in Children With Hyperphosphatemia Related to Chronic Kidney Disease
This study will be conducted to assess the safety and tolerability of ferric citrate in pediatric participants with hyperphosphatemia related to chronic kidney disease (CKD).
- Trial name
- NCT04523727
- Testing
- ferric citrate
- Where
- 14 sites in United States
- Volunteers
- 45 people
- Sponsor
- Keryx Biopharmaceuticals
Acne Vulgaris
Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo
This study is to evaluate the safety, pharmacokinetics, and treatment effect for topically applied CABTREO lotion in pediatric participants ages 9 to 11 years, 11 months with Acne Vulgaris.
- Trial name
- NCT07524946
- Testing
- CABTREO is a fixed-combination product of clindamycin phosphate 1.2%/BPO 3.1%/adapalene 0.15%.
- Where
- 15 sites in United States
- Volunteers
- 100 people
- Sponsor
- Bausch Health Americas, Inc.
Chronic Hepatitis B
Study to Evaluate the Antiviral Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Participants With Chronic Hepatitis B Infection
The primary objective of this study is to evaluate the antiviral efficacy of tenofovir disoproxil fumarate (tenofovir DF; TDF) versus placebo in pediatric population (aged 2 to < 12 years at the time of enrollment) with chronic…
- Trial name
- NCT01651403
- Testing
- Tenofovir DF
- Where
- 21 sites in United States, India and 3 more
- Volunteers
- 90 people
- Sponsor
- Gilead Sciences
Vaccines, Pneumococcal Conjugate Vaccine
Study Evaluating A 13-Valent Pneumococcal Conjugate Vaccine Administered to Infants in Taiwan
The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate vaccine (13vPnC), relative to a 7-valent pneumococcal conjugate vaccine (7vPnC) when given concomitantly…
- Trial name
- NCT00688870
- Testing
- 13-valent pneumococcal conjugate vaccine (13vPnC), 7-valent pneumococcal conjugate vaccine (7vPnC)
- Where
- 2 sites in Taiwan
- Volunteers
- 168 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Reperfusion Injury, Post Cardiac Arrest Brain Injury
Light Utilization COX-Inhibitory Device Therapy for Infant Cardiac Arrest (LUTICA Study). The LUCID Device is Used in the Treatment of Ischemic Brain Reperfusion Injury Caused by Cardiac Arrest in Pediatric Patients.
Approximately 15,200 children receive cardiopulmonary resuscitation (CPR) for in-hospital cardiac arrest (IHCA) each year in the United States. Of these, about 60% are less than one year of age.
- Trial name
- LUTICA (NCT07556939)
- Testing
- LUTICIA - Light Utilization COX-Inhibitory Device)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Mitovation, Inc
Medulloblastoma, Rhabdomyosarcoma
A Phase I Dose Finding and Safety Study of Oral LDE225 in Children and a Phase II Portion to Assess Preliminary Efficacy in Recurrent or Refractory MB
Phase I dose-escalation study to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of LDE225 given orally on a daily dosing schedule in children with recurrent or refractory medulloblastoma, or other…
- Conditions
- Medulloblastoma, Rhabdomyosarcoma, Neuroblastoma, Hepatoblastoma
- Trial name
- NCT01125800
- Testing
- LDE225
- Where
- 14 sites in United States, Australia and 4 more
- Volunteers
- 76 people
- Sponsor
- Novartis Pharmaceuticals
Partial Seizures
A Study of Levetiracetam as Monotherapy or Adjunctive Treatment of Partial Seizures in Pediatric Epileptic Subjects Ranging From 1 Month to Less Than 4 Years of Age
This is a study to confirm the efficacy of levetiracetam as adjunctive treatment or as monotherapy in pediatric epilepsy subjects aged 1 month to less than 4 years of age with partial seizures.
- Trial name
- PEACH (NCT03340064)
- Testing
- Levetiracetam
- Where
- 21 sites in Japan
- Volunteers
- 38 people
- Sponsor
- UCB Japan Co. Ltd.
Cough, Wheezing
A Methodology Trial Using the VR647 Inhalation System in Pediatric Subjects Who Have Previously Received Inhaled Therapy
This is an open-label, non-drug methodology trial in which subjects undergo a stepwise series of tests to evaluate their ability to use a mouthpiece to deliver nebulized therapy.
- Trial name
- NCT04011709
- Testing
- VR647 Inhalation System + VR647 Smart Card 3 Secs, VR647 Inhalation System + VR647 Smart Card 2 Secs, VR647 Inhalation System + VR647 Smart Card 4 Secs
- Where
- 5 sites in United States
- Volunteers
- 41 people
- Sponsor
- Vectura Limited
Primary Fibromyalgia
Long-Term Safety and Efficacy Study of Milnacipran in Pediatric Patients With Primary Fibromyalgia
The purpose of this study is to evaluate the long-term safety and efficacy of milnacipran in pediatric patients aged 13 to 17 years with primary fibromyalgia.
- Trial name
- MyFi (NCT01331109)
- Testing
- Milnacipran
- Where
- 31 sites in United States
- Volunteers
- 57 people
- Sponsor
- Forest Laboratories
Lymphoma, Non-Hodgkin
A Safety and Efficacy Study of Ibrutinib in Pediatric and Young Adult Participants With Relapsed or Refractory Mature B-cell Non-Hodgkin Lymphoma
The purpose of this study is to confirm that the pharmacokinetics of ibrutinib in pediatric participants is consistent with that in adults (part 1) and to assess efficacy (event-free survival [EFS]) of ibrutinib in combination…
- Trial name
- NCT02703272
- Testing
- Ibrutinib, Rituximab, Ifosfamide
- Where
- 76 sites in United States, Belgium and 18 more
- Volunteers
- 72 people
- Sponsor
- Janssen Research & Development, LLC
Arthritis Juvenile Idiopathic
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase.
- Trial name
- NCT03000439
- Testing
- In open-label phase: treatment with tofacitinib
- Where
- 52 sites in United States, Argentina and 17 more
- Volunteers
- 100 people
- Sponsor
- Pfizer
Cushing Syndrome
Pharmacokinetic (PK), Pharmacodynamic (PD) and Tolerability of Osilodrostat in Pediatric Patients With Cushing's Syndrome
Multicenter, open-label, non-comparative study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of osilodrostat in children and adolescent patients with Cushing's syndrome.
- Trial name
- NCT03708900
- Testing
- LCI699
- Where
- 15 sites in United States, Belgium and 5 more
- Volunteers
- 12 people
- Sponsor
- RECORDATI GROUP
Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia
Evaluating the Safety and Performance of the MiniLung Petite Kit in Neonatal and Pediatric Patients With Acute Respiratory and Cardiac Failure
This prospective observational study will evaluate the safety and performance of the MiniLung petite kit in neonatal and pediatric patients with acute respiratory and cardiac failure.
- Conditions
- Extracorporeal Membrane Oxygenation Complication, Neonatal Aspiration Pneumonia, Acute Respiratory Failure, Acute Lung Injury
- Trial name
- PETIT (NCT06750536)
- Testing
- MiniLung petite kit combined with the Xenios console
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Xenios AG
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