Clinical trials: Pediatric Population
Congenital Hemophilia A
Pharmacokinetic, Efficacy, and Safety Study of Recombinant Factor VIII Single Chain (rVIII-SingleChain) in Children With Severe Hemophilia A
This is an international, multicenter, open-label study to assess the efficacy, safety, and pharmacokinetic (PK) profile of rVIII-SingleChain in pediatric patients with severe hemophilia A.
- Trial name
- NCT02093897
- Testing
- rVIII-SingleChain
- Where
- 37 sites in United States, Australia and 17 more
- Volunteers
- 84 people
- Sponsor
- CSL Behring
Atopic Dermatitis
Comparison Trial of OPA-15406 Ointment in Pediatric Patients With Atopic Dermatitis
To demonstrate the superiority of the investigational medicinal product (IMP; 0.3% OPA-15406 ointment, 1% OPA-15406 ointment, or vehicle) to the vehicle when administered twice daily for 4 weeks using success rate in…
- Trial name
- NCT03911401
- Testing
- 0.3% OPA-15406, 1% OPA-15406
- Where
- Japan
- Volunteers
- 251 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Allergic Rhinitis
Hypothalamic-Pituitary-Adrenal (HPA)-Axis Study in Pediatric Subjects With Perennial Allergic Rhinitis (PAR)
The purpose of this study is to compare the effect of 6 weeks of treatment with beclomethasone dipropionate (BDP) nasal aerosol versus placebo on HPA-axis function, as assessed by 24-hour serum cortisol weighted mean, and to…
- Trial name
- NCT01697956
- Testing
- BDP
- Where
- 6 sites in United States
- Volunteers
- 99 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Epileptic Encephalopathy, Continuous Spike and Wave During Sleep
Efficacy, Safety, Tolerability, and Pharmacokinetics of NBI-827104 in Pediatric Subjects With Epileptic Encephalopathy With Continuous Spike-and-Wave During Sleep
This is a phase 2, double-blind study to assess the efficacy, safety, tolerability, and pharmacokinetics of NBI-827104 when administered once daily for 13 weeks in pediatric subjects with Epileptic Encephalopathy with Continuous…
- Trial name
- NCT04625101
- Testing
- NBI-827104
- Where
- 15 sites in United States, Canada and 4 more
- Volunteers
- 24 people
- Sponsor
- Neurocrine Biosciences
Depression, Bipolar I Disorder
A Study to Assess Change in Disease Activity and Adverse Events (AEs) With Cariprazine in the Treatment of Depressive Episodes in Pediatric Participants Participants (10 to 17 Years of Age) With Bipolar I Disorder.
Bipolar disorder is a severe chronic mood disorder that affects up to 4% of the adult population and 1.8% of the pediatric population in the United States.
- Trial name
- 3112 Ped BPD (NCT04777357)
- Testing
- Cariprazine
- Where
- 81 sites in United States, Puerto Rico and 1 more
- Volunteers
- 380 people
- Sponsor
- AbbVie
Secondary Hyperparathyroidism-Chronic Kidney Disease
Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
Primary Objective: Evaluated the effect of Hectorol® capsules in reducing elevated levels of intact parathyroid hormone (iPTH). Secondary Objectives: Evaluated the safety profile of Hectorol® capsules versus Rocaltrol®…
- Trial name
- NCT02859896
- Testing
- Doxercalciferol (GZ427397), Calcitriol
- Where
- 23 sites in United States, Chile
- Volunteers
- 21 people
- Sponsor
- Sanofi
Invasive Pneumococcal Disease
Study Evaluating Prevenar in the Prevention of Invasive Pneumococcal Disease (IPD) in the Paediatric Population in Spain.
The aim of this study is to evaluate the postlicensure effectiveness of Prevnar in the prevention of IPD in the Spanish paediatric population (children younger than 5 years)
- Trial name
- NCT00227188
- Testing
- Pneumococcal 7-valent conjugate vaccine Prevnar
- Where
- Spain
- Volunteers
- 408 people
- Sponsor
- Pfizer
Atopic Dermatitis (AD)
To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients with AD
A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD.
- Trial name
- NCT05650320
- Testing
- 0.3% OPA-15406 Ointment, 1% OPA-15406 Ointment, 0% OPA-15406 vehicle
- Where
- China
- Volunteers
- 240 people
- Sponsor
- Otsuka Beijing Research Institute
Hypertension
A Study to Evaluate the Efficacy and Safety of Eplerenone in the Treatment of Hypertension in Children.
To evaluate the efficacy, safety, and toleration of eplerenone in the treatment of children aged 6 to 16 years with high blood pressure. The study will last approximately 10 weeks and about 320 patients will participate.
- Trial name
- NCT00147589
- Testing
- Eplerenone
- Where
- 41 sites in United States, Dominican Republic and 3 more
- Volunteers
- 320 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Local Anesthetic
Efficacy and Safety of Chloroprocaine 3% Gel and Oxybuprocaine 0.4% Eye Drops Anesthesia in Pediatric Population
The goal of this clinical trial is to assess the efficacy and safety of Chloroprocaine 3% eye gel compared to Oxybuprocaine 0,4% eye drops when used for inducing ocular surface anesthesia in pediatric patients.
- Trial name
- NCT05926258
- Testing
- Chloroprocaine 3% eye gel, Oxybuprocaine Hydrochloride 4 Mg/mL Eye Drops
- Where
- 3 sites in Italy
- Volunteers
- 74 people
- Sponsor
- Sintetica SA
Fabry Disease
A Study of Two Fabrazyme (Agalsidase Beta) Dosing Regimens in Treatment-naïve, Male Pediatric Patients Without Severe Symptoms
The purpose of this study was to determine whether 2 alternative dosing regimens of Fabrazyme (Agalsidase beta) (1.0 mg/kg every 4 weeks or 0.5 mg/kg every 2 weeks) were effective in treatment-naïve pediatric participants without…
- Trial name
- FIELD (NCT00701415)
- Testing
- Agalsidase beta
- Where
- 12 sites in United States, Argentina and 7 more
- Volunteers
- 31 people
- Sponsor
- Genzyme, a Sanofi Company
Colitis, Ulcerative
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction…
- Trial name
- QUASAR Jr (NCT06260163)
- Testing
- Guselkumab Subcutaneous, Guselkumab Intravenous
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Primary Hypercholesterolemia
Pediatric Study to Evaluate the Efficacy and Safety of Ezetimibe Monotherapy in Children With Primary Hypercholesterolemia (P05522)
The purpose of this study is to determine the effect of ezetimibe 10 mg/day compared to placebo on the reduction of low-density lipoprotein cholesterol (LDL-C) from baseline to 12 weeks of treatment in children >=6 to <=10 years…
- Trial name
- NCT00867165
- Testing
- ezetimibe
- Volunteers
- 138 people
- Sponsor
- Organon and Co
Pneumococcal Meningitis
Study Evaluating Pneumococcal Meningitis in the Paediatric Population in Spain Four Years After the Marketing of Prevenar.
The aim of this study is to determine the prevalence of pneumococcal meningitis in the paediatric population in Spain four years after the marketing of Prevenar.
- Trial name
- NCT00227214
- Where
- 39 sites in Spain
- Volunteers
- 160 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer