Clinical trials: Pediatric Safety and Effectiveness
Hyperphosphatemia, Chronic Kidney Disease
An Efficacy and Safety Study of Sevelamer Carbonate in Hyperphosphatemic Pediatric Participants With Chronic Kidney Disease
Objective: In hyperphosphatemic pediatric participants with chronic kidney disease (CKD) to Evaluate the safety and tolerability of sevelamer carbonate Evaluate the efficacy of sevelamer carbonate on the control of serum…
- Trial name
- NCT01574326
- Testing
- Sevelamer carbonate
- Where
- 32 sites in United States, France and 3 more
- Volunteers
- 101 people
- Sponsor
- Genzyme, a Sanofi Company
HIV Infections
Safety and Effectiveness of Adding Adefovir Dipivoxil and Nelfinavir to the Anti-HIV Therapy of HIV-Infected Children
The purpose of this study is to see if it is safe and effective to give adefovir (a new anti-HIV drug) plus nelfinavir to HIV-infected children who are already receiving other anti-HIV medications.
- Trial name
- NCT00002219
- Testing
- Nelfinavir mesylate, Levocarnitine, Adefovir dipivoxil
- Where
- 7 sites in United States
- Volunteers
- 36 people
- Sponsor
- Gilead Sciences
Heart Murmurs, Wheezing
Validate the Efficacy and the Safety of the Keikku Electronic Stethoscope for Its Indication and Intended Purpose, Under the Intended Conditions of Use.
This study is testing a digital stethoscope called the Keikku electronic stethoscope. Doctors use stethoscopes to listen to the heart, and this new device records heart sounds using a smartphone app.
- Trial name
- KCI-1 (NCT07044128)
- Testing
- Digital stethoscope using MEMS sensor and mobile application for cardiac auscultation
- Where
- Peru
- Volunteers
- 149 people, healthy volunteers welcome
- Sponsor
- Lapsi Health Holding B.V.
Central Nervous System Diseases, Pediatric Disorder
Gadopiclenol Pharmacokinetics, Safety and Efficacy in Children < 2 Years of Age
This Phase II open-label, uncontrolled, multicenter trial is designed to investigate the pharmacokinetic (PK) profile of gadopiclenol in plasma, in pediatric patients aged up to 23 months inclusive (term neonates or preterm…
- Conditions
- Central Nervous System Diseases, Pediatric Disorder, Body Indication
- Trial name
- NCT05590884
- Testing
- Gadopiclenol
- Where
- 11 sites in United States, Hungary and 1 more
- Volunteers
- 36 people
- Sponsor
- Guerbet
Atopic Dermatitis
Open-label Study to Investigate Systemic Exposure in Adult and Pediatric Atopic Dermatitis Patients Treated 8.5 Days With Pimecrolimus Cream 1% Under Occlusion
This study will access the degree to which pimecrolimus is absorbed from pimecrolimus cream 1% into the blood when applied repeatedly under occlusion (i.e.
- Trial name
- NCT00925730
- Testing
- Pimecrolimus
- Where
- 2 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Novartis
Acute Kidney Injury
A Multi-Center Study of a SCD for Immunomodulatory Dysregulation in Pediatric AKI
The SCD PED-02 trial is examining the safety and efficacy of the Selective Cytopheretic Device (SCD) in treating pediatric acute kidney injury (AKI).
- Trial name
- SCD PED-02 (NCT04869787)
- Testing
- Selective Cytopheretic Device
- Where
- 2 sites in United States
- Volunteers
- 7 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
H Pylori Gastritis
Comparison of Efficacy of Triple Regimen Based on Clarithromycin VS Metronidazole in Children
All children from 1day to 18years of age, diagnosed with peptic ulcer disease due to H pylori at Pakistan Institute of Medical Sciences, Islamabad, from July 2020 to December 2021 will be included in the study.
- Trial name
- CETR (NCT04721704)
- Testing
- Clarithromycin+ Amoxicillin + Omeprazole, Metronidazole +Amoxicillin + Omeprazole
- Where
- 2 sites in Pakistan
- Volunteers
- 36 people
- Sponsor
- Shaheed Zulfiqar Ali Bhutto Medical University
Moderate to Severe Plaque Psoriasis
A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Ustekinumab in Children and Adolescents From 6 Years to Less Than 18 Years of Age With Moderate to Severe Plaque Psoriasis
The primary purpose of this study is to evaluate the efficacy of bimekizumab administered subcutaneously (sc) compared to active control (ustekinumab) in children and adolescents aged 6 to <18 years of age with moderate to severe…
- Trial name
- BE TOGETHER (NCT06425549)
- Testing
- bimekizumab, ustekinumab
- Where
- 42 sites in United States, Belgium and 8 more
- Volunteers
- 176 people
- Sponsor
- UCB Biopharma SRL
Acute Graft-versus-host Disease
Safety and Efficacy of Itacitinib in Combination With Corticosteroids for Treatment of Graft-Versus-Host Disease in Pediatric Subjects
The purpose of this study is to evaluate itacitinib in combination with corticosteroids for the treatment of Grades II to IV acute graft-versus-host disease (aGVHD) in steroid-naive pediatric participants.
- Trial name
- NCT03721965
- Testing
- Itacitinib, Corticosteroids
- Where
- 38 sites in United States, France and 4 more
- Volunteers
- 2 people
- Sponsor
- Incyte Corporation
Relapsed or Refractory Solid Tumors or Lymphoma in Children, Neuroblastoma
Safety, Tolerability, Efficacy and Pharmacokinetics of Copanlisib in Pediatric Patients
This study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.
- Conditions
- Relapsed or Refractory Solid Tumors or Lymphoma in Children, Neuroblastoma, Osteosarcoma, Rhabdomyosarcoma
- Trial name
- NCT03458728
- Testing
- Copanlisib (BAY806946)
- Where
- 14 sites in United States
- Volunteers
- 31 people
- Sponsor
- Bayer
Ulcerative Colitis
Safety and Efficacy of MMX Mesalamine/Mesalazine in Pediatric Subjects With Mild to Moderate Ulcerative Colitis
To assess clinical response to MMX mesalamine/mesalazine between a low and high dose in children and adolescents aged 5-17 years with mild to moderate Ulcerative Colitis (UC) or who are in remission.
- Trial name
- PACE (NCT02093663)
- Testing
- MMX Mesalamine/Mesalazine (Low Dose), MMX Mesalamine/Mesalazine (High Dose)
- Where
- 33 sites in United States, Canada and 5 more
- Volunteers
- 107 people
- Sponsor
- Shire
Influenza
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to <12 years of age) with…
- Trial name
- NCT03629184
- Testing
- Baloxavir Marboxil, Oseltamivir
- Where
- 37 sites in United States, Costa Rica and 5 more
- Volunteers
- 173 people
- Sponsor
- Hoffmann-La Roche
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
Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)
The overall objective of this study is to evaluate the pharmacokinetics (PK), efficacy, and safety of encaleret in pediatric participants from birth to 17 years of age with ADH1.
- Trial name
- CALIBRATE-PEDS (NCT07080385)
- Testing
- Encaleret
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio company
Pediatric Subjects With Diabetes Mellitus
Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus
The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus.
- Trial name
- NCT01667185
- Where
- 6 sites in United States
- Volunteers
- 176 people
- Sponsor
- DexCom, Inc.
Vernal Keratoconjunctivitis
Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis
The objective of this study is to compare the efficacy of two different dosing regimen of NOVA22007 (1mg/ml ciclosporin/cyclosporine) eye drops, emulsion versus placebo (vehicle of the formulation) administered four times a day…
- Trial name
- NCT01751126
- Testing
- NOVA22007 ''Ciclosporin''
- Where
- 46 sites in United States, Croatia and 9 more
- Volunteers
- 169 people
- Sponsor
- Santen SAS
Multiple Sclerosis
Efficacy, Safety and Pharmacokinetics of Teriflunomide in Pediatric Patients With Relapsing Forms of Multiple Sclerosis
Primary Objective: To assess the effect of teriflunomide in comparison to placebo on disease activity measured by time to first clinical relapse after randomization in children and adolescents 10 to 17 years of age with relapsing…
- Trial name
- TERIKIDS (NCT02201108)
- Testing
- Teriflunomide
- Where
- 57 sites in United States, Belgium and 20 more
- Volunteers
- 166 people
- Sponsor
- Genzyme, a Sanofi Company
Thrombocytopenia, Immune
Safety and Efficacy Study of QL0911 to Treat Immune Thrombocytopenia (ITP) in Pediatric Patients
The purpose of this study is to evaluate efficacy and of safety QL0911 in the treatment of thrombocytopenia in pediatric patients with previously treated chronic ITP.
- Trial name
- NCT07455006
- Testing
- QL0911
- Volunteers
- 60 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Hemophilia A
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in Previously Treated Pediatric Subjects With Hemophilia A
The primary objective of the study is to evaluate the safety of Recombinant Coagulation Factor VIII Fc Fusion Protein (rFVIIIFc) in previously treated pediatric subjects with hemophilia A.
- Trial name
- Kids ALONG (NCT01458106)
- Testing
- BIIB031 (rFVIIIFc), FVIII (PK subgroup only)
- Where
- 23 sites in United States, Australia and 6 more
- Volunteers
- 71 people
- Sponsor
- Bioverativ Therapeutics Inc.
Crohn's Disease
Efficacy and Long Term Safety of Adalimumab in Pediatric Subjects Who Have Demonstrated Clinical Response in M06-806
This was a multicenter, open-label study to evaluate the human monoclonal anti-TNF-α antibody adalimumab as an effective therapy for maintaining clinical response in pediatric participants with Crohn's disease (CD) and to gather…
- Trial name
- NCT00686374
- Testing
- Adalimumab
- Volunteers
- 100 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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