Clinical trials: Pediatric Safety and Effectiveness
Arthritis, Juvenile
A Study of Ustekinumab or Guselkumab in Pediatric Participants With Active Juvenile Psoriatic Arthritis
The purpose of this study is to evaluate the pharmacokinetics (PK), efficacy, safety and immunogenicity of ustekinumab and guselkumab in active juvenile psoriatic arthritis (jPsA).
- Trial name
- PSUMMIT-Jr (NCT05083182)
- Testing
- Ustekinumab, Guselkumab
- Where
- 50 sites in United States, Argentina and 8 more
- Volunteers
- 48 people
- Sponsor
- Janssen Research & Development, LLC
Severe Influenza
Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms
This is a multicenter, randomized, open Label, add-on study.
- Trial name
- NCT03947411
- Testing
- Oseltamivir Phosphate, Xiyanping injection+Oseltamivir Phosphate
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Other Acute Postoperative Pain, Prolonged Endotracheal Intubation
Pharmacokinetics, Safety, and Efficacy of Intravenous Dosing of Buprenorphine in Pediatric Patients Who Require Opioid Analgesia for Acute Moderate to Severe Pain
The purpose of this study is to characterize the safety, pharmacokinetics (PK), and efficacy of intravenous (IV) buprenorphine in pediatric patients.
- Trial name
- NCT01324544
- Testing
- Buprenorphine IV
- Sponsor
- Purdue Pharma LP
Acute Focal Appendicitis, Appendicitis
Non-operative Management for Appendicitis in Children
This study is designed to determine the safety and efficacy of non-operative antibiotic management of clinically diagnosed acute uncomplicated appendicitis in children.
- Trial name
- APRES (NCT02795793)
- Testing
- Non-operative management group (NOM), Appendectomy group (Operative management, OM)
- Where
- 2 sites in Australia
- Volunteers
- 226 people
- Sponsor
- Sydney Children's Hospitals Network
MPS II, Hunter Syndrome (MPS II)
RGX-121-3102 Gene Therapy in Participants With MPS II (Hunter Syndrome)
RGX-121 is a gene therapy which is intended to deliver a functional copy of the iduronate-2-sulfatase gene (IDS) to the central nervous system.
- Trial name
- NCT07236606
- Testing
- RGX-121-3102
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- REGENXBIO Inc.
Controlling Mild to Moderate Bleeding During Surgery
The EVARREST® Pediatric Mild or Moderate Liver and Soft Tissue Bleeding Study
The objective of this study is to evaluate the safety and hemostatic effectiveness of EVARREST as an adjunct to controlling mild to moderate soft hepatic parenchyma or soft tissue bleeding during open hepatic, abdominal, pelvic…
- Trial name
- NCT03255174
- Testing
- EVARREST® Fibrin Sealant Patch
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Ethicon, Inc.
Attention Deficit Hyperactivity Disorder (ADHD)
A Long Term Post-Marketing Study on the EffIcacy and Safety of Osmotic Release Oral System (OROS) Methylphenidate on the Cognitive Functions of Attention Deficit Hyperactivity Disorder (ADHD) Participants
The purpose of this long term post-marketing study is to evaluate the effectiveness and safety of osmotic release oral system methylphenidate hydrochloride (OROS-MPH) in participants with Attention Deficit Hyperactivity Disorder…
- Trial name
- NCT01933880
- Testing
- Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH), No intervention
- Where
- 6 sites in China
- Volunteers
- 194 people, healthy volunteers welcome
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Upper Respiratory Tract Infections
A Randomized, Double-blind, Placebo-controlled Study on the Efficacy and Safety of CVT-E002 in the Treatment of Upper Respiratory Tract Infections in a Pediatric (3-11 Years) Population
Parents with children aged 3-11 will participate in this study. About 500 children will take part in the study. We expect about half of those children will develop symptoms of a respiratory infection.
- Trial name
- NCT00965822
- Testing
- North American ginseng
- Where
- 4 sites in Canada
- Volunteers
- 293 people, healthy volunteers welcome
- Sponsor
- Afexa Life Sciences Inc
Malnutrition
Study to Assess Safety and Efficacy of Kabiven® in Pediatric Patients 2 to 16 Years of Age
Demonstrate the safety and efficacy of Kabiven compared to standard parenteral nutrition (PN) administered via central vein in pediatric patients (2 to 16 years of age) requiring PN to meet nutritional needs.
- Trial name
- NCT03481894
- Testing
- Kabiven®, Compounded standard parenteral nutrition
- Where
- 2 sites in United States
- Sponsor
- Fresenius Kabi
Acute Stress Disorder, Anxiety
Safety & Efficacy of Intranasal Dexmedetomidine, Fentanyl & Midazolam in the Pediatric Emergency Room
The hypothesis is that intranasal dexmedetomidine will provide significantly more effective analgesia and anxiolysis for subjects undergoing a simple laceration repair when compared to either intranasal fentanyl or intranasal…
- Conditions
- Acute Stress Disorder, Anxiety, Pain
- Trial name
- NCT05057689
- Testing
- Intranasal Dexmedetomidine (4 mcg/kg), Intranasal Fentanyl (2 mcg/kg), Intranasal Midazolam (5 mg/kg)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Nationwide Children's Hospital
Progressive Familial Intrahepatic Cholestasis
Long Term Safety & Efficacy Study Evaluating The Effect of A4250 in Children With PFIC
Open-label extension study to evaluate long-term safety and persistence of effect of A4250 in children with progressive familial intrahepatic cholestasis (PFIC).
- Trial name
- PEDFIC 2 (NCT03659916)
- Testing
- A4250 (odevixibat)
- Where
- 41 sites in United States, Australia and 13 more
- Volunteers
- 116 people
- Sponsor
- Albireo, an Ipsen Company
Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Adenitis Syndrome
Efficacy and Safety of Thalidomide for Pediatric PFAPA Syndrome
The goal of this clinical trial is to evaluate the efficacy and safety of thalidomide in the treatment of children with Periodic Fever, Aphthous Stomatitis, Pharyngitis, and Adenitis (PFAPA) syndrome.
- Trial name
- NCT07476625
- Testing
- Thalidomide (50mg), Colchicine
- Volunteers
- 106 people
- Sponsor
- Wenjie Zheng
Major Depressive Disorder
A Study of Vortioxetine in Japanese Pediatric Patients With Major Depressive Disorder
The main aim of the study is to check how well vortioxetine 10 mg/day or 20 mg/day works and to check for side effects compared to a placebo on depression symptoms in Japanese teenagers aged 12 to 17 years with a diagnosis of…
- Trial name
- NCT07204314
- Testing
- Vortioxetine tablets
- Where
- 30 sites in Japan
- Volunteers
- 180 people
- Sponsor
- Takeda
Short Bowel Syndrome, Cholestasis
Efficacy and Safety of Omega-3 Lipid Therapy in Pediatric Patients With Parenteral Nutrition-Associated Liver Disease
This pilot study seeks to demonstrate the efficacy of an intravenous lipid preparation high in omega-3 fatty acids (Omegaven) in the treatment of cholestasis in parenteral nutrition dependent patients with short gut syndrome.
- Trial name
- NCT01739517
- Testing
- Omegaven Therapy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Amarnath, Rathna, M.D.
Mucopolysaccharidosis IVA, Morquio A Syndrome
Study of BMN 110 in Pediatric Patients < 5 Years of Age With Mucopolysaccharidosis IVA (Morquio A Syndrome)
This open-label Phase 2 study will evaluate the safety and efficacy of weekly 2.0 mg/kg/wk infusions of BMN 110 in pediatric patients, less than 5 years of age at the time of administration of the first dose of study drug…
- Conditions
- Mucopolysaccharidosis IVA, Morquio A Syndrome, MPS IVA
- Trial name
- NCT01515956
- Testing
- BMN 110
- Where
- 5 sites in United States, Italy and 2 more
- Volunteers
- 15 people
- Sponsor
- BioMarin Pharmaceutical
Lice Infestations
Safety and Efficacy of a Novel Malathion Formulation in the Treatment of Head Lice
Current treatments for head lice include over-the-counter products such as permethrin and prescription products such as OVIDE (malathion 0.5%) lotion.
- Trial name
- NCT00244439
- Testing
- MALG, Ovide (malathion) lotion 0.05%, Permethrin 1%
- Where
- 6 sites in United States
- Volunteers
- 360 people
- Sponsor
- Sun Pharmaceutical Industries, Inc.
Hemophilia A
Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A
Primary Objective: To evaluate the safety of BIVV001 in previously treated pediatric participants with hemophilia A. Secondary Objectives: To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
- Trial name
- XTEND-Kids (NCT04759131)
- Testing
- efanesoctocog alfa (BIVV001)
- Where
- 40 sites in United States, Australia and 13 more
- Volunteers
- 74 people
- Sponsor
- Bioverativ, a Sanofi company
Low-grade Glioma, Advanced Solid Tumor
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
This is a Phase 2, multi center, open-label study to evaluate the safety and efficacy of Type II RAF (tovorafenib) in pediatric participants with low-grade glioma or advanced solid tumors.
- Trial name
- FIREFLY-1 (NCT04775485)
- Testing
- Tovorafenib
- Where
- 35 sites in United States, Australia and 9 more
- Volunteers
- 141 people
- Sponsor
- Day One Biopharmaceuticals, Inc.
Anemia Associated With Chronic Kidney Disease
Investigating the Efficacy and Safety of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
This open-labeled, one-center study is designed to evaluate the efficacy and safety of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5 who are receiving dialysis or not.
- Trial name
- NCT04925011
- Testing
- Roxadustat
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Mao Jianhua
Scoliosis Idiopathic, Scoliosis; Adolescence
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
This study will evaluate whether tranexamic acid (TXA), a medication used to reduce bleeding, is effective and safe in children undergoing surgery for idiopathic scoliosis.
- Trial name
- NCT07581457
- Testing
- Tranexamic Acid Bolus Plus Infusion, Sodium Chloride 0.9% Inj, Tranexamic Acid Bolus Only
- Where
- Poland
- Volunteers
- 90 people
- Sponsor
- Poznan University of Medical Sciences
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