Clinical trials: Pediatric Disease
Asthma
Pediatric Ease of Use ELLIPTA Items
A range of devices has been developed to administer inhaled therapy for asthma, including dry powder inhaler (DPI) devices. ELLIPTA is a DPI that is preloaded with a drug therapy to treat asthmatic subjects.
- Trial name
- NCT03315572
- Testing
- Interviewer administered version of ease of use items, Self-administered version of ease of use items, Caregiver version of ease of use items
- Where
- 2 sites in United States
- Volunteers
- 28 people
- Sponsor
- GlaxoSmithKline
Myelodysplastic Syndrome, Leukemia, Myelomonocytic, Juvenile
Study With Azacitidine in Pediatric Subjects With Newly Diagnosed Advanced Myelodysplastic Syndrome (MDS) and Juvenile Myelomonocytic Leukemia (JMML)
Indication Treatment of pediatric subjects with newly diagnosed advanced myelodysplastic syndrome (MDS) or juvenile myelomonocytic leukemia (JMML) prior to hematopoietic stem cell transplantation (HSCT).
- Trial name
- NCT02447666
- Testing
- Azacitidine
- Where
- 39 sites in Austria, Belgium and 11 more
- Volunteers
- 28 people
- Sponsor
- Celgene
Obsessive Compulsive Disorder
Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES)
To evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety…
- Trial name
- SPRITES (NCT01302080)
- Testing
- sertraline, psychotherapy
- Where
- 44 sites in United States
- Volunteers
- 941 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Neuromyelitis Optica Spectrum Disorder
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).
- Trial name
- NCT05346354
- Testing
- Ravulizumab
- Where
- 16 sites in United States, Canada and 5 more
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Myasthenia Gravis, Myasthenia Gravis, Juvenile Form
A Phase 3 Open-Label Study of Eculizumab in Pediatric Participants With Refractory Generalized Myasthenia Gravis (gMG)
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of eculizumab in the treatment of pediatric refractory gMG based on change from Baseline in the Quantitative Myasthenia Gravis…
- Conditions
- Myasthenia Gravis, Myasthenia Gravis, Juvenile Form, Myasthenia Gravis, Generalized
- Trial name
- NCT03759366
- Testing
- Eculizumab
- Where
- 11 sites in United States, Japan
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Tourette's Syndrome
A Study of the Effectiveness and Safety of Tetrabenazine MR in Pediatric Subjects With Tourette's Syndrome
The purpose of this clinical trial is to study the therapeutic effect of tetrabenazine MR in children with Tourette's Syndrome, as measured by the improvement in total tic score of the Yale Global Tic Severity Scale (YGTSS).
- Trial name
- TBZ-MR (NCT01133353)
- Testing
- Tetrabenazine MR
- Sponsor
- Bausch Health Americas, Inc.
Atopic Dermatitis
A Long-term Study of the Medicine Called Abrocitinib in Children Aged 2 Years and Older With Moderate to Severe Eczema
This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis.
- Trial name
- NCT06807281
- Testing
- Abrocitinib
- Where
- 39 sites in United States, China and 5 more
- Volunteers
- 450 people
- Sponsor
- Pfizer
Type 2 Spinal Muscular Atrophy
Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)
This was a Phase III multi-center, single dose (1.2 x 10^14 vector genomes), randomized, sham controlled, double-blind study that investigates the efficacy, safety and tolerability of OAV101B in treatment naive, sitting and never…
- Trial name
- STEER (NCT05089656)
- Testing
- OAV101
- Where
- 42 sites in United States, Brazil and 11 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Central Nervous System Disease, Central Nervous System Neoplasms
Retrospective Study of MRI in Pediatric Patients
Collection of already existing data and images for patients < 2 years of age having MultiHance administration for a MRI of the brain or spine.
- Trial name
- NCT02291822
- Testing
- Gadobenate Dimeglumine
- Volunteers
- 90 people
- Sponsor
- Bracco Diagnostics, Inc
Hereditary Tyrosinemia, Type I
A Non-interventional, Post-Marketing Study to Describe Outcome of Nitisinone Treatment in HT-1 Patients
This is a prospective, non-interventional, non-comparative, multicenter study to collect data on HT-1 patients in China treated with Nitisinone in a routine clinical setting. No tests or examinations are mandated in the study.
- Trial name
- NCT06227429
- Testing
- Nitisinone
- Where
- 4 sites in China
- Sponsor
- Swedish Orphan Biovitrum
Lupus Nephritis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants
This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with…
- Trial name
- POSTERITY (NCT05039619)
- Testing
- Obinutuzumab, Mycophenolate Mofetil, Acetaminophen/paracetamol
- Where
- 44 sites in United States, Brazil and 10 more
- Volunteers
- 40 people
- Sponsor
- Hoffmann-La Roche
Varicella
Safety and Efficacy of Varicella Zoster Immune Globulin (Human) VariZIG in Patients at Risk of Varicella Infection
This study is to assess VariZIG™ for the treatment of patients at risk for developing serious complications from chicken pox.
- Trial name
- NCT00338442
- Testing
- VariZIG™
- Sponsor
- Cangene Corporation
Ear Infection
Application of the Belle.AI Comparative Image Reference System for Describing Chronic Ear Infections in Pediatric Patients From Low-Resource Communities
The purpose of this research is to examine the clinical effectiveness of an investigational AI-powered smartphone app that describes the physical characteristics of an otoscopy image. It is not intended to make any diagnosis.
- Trial name
- Otoscopy AI (NCT07025473)
- Testing
- Smartphone-enabled otoscopy
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- BelleTorus Corporation
Influenza
Study to Assess the Tolerability, Safety and Efficacy of GP681 Powder for Oral Suspension
This study aims to evaluate the tolerability, safety, pharmacokinetic characteristics and efficacy of a single oral dose of GP681 powder for oral suspension in pediatric and adolescent patients with uncomplicated influenza.
- Trial name
- NCT06643156
- Testing
- GP681 10mg/20mg/40mg
- Where
- China
- Volunteers
- 44 people
- Sponsor
- Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Angelman Syndrome
Phase 3 Efficacy and Safety Study of GTX-102 in Pediatric Subjects With Angelman Syndrome (AS)
The primary objective of this study is to evaluate the effect of GTX-102 in cognitive function in participants with deletion-type Angelman Syndrome (AS).
- Trial name
- Aspire (NCT06617429)
- Testing
- GTX-102
- Where
- 28 sites in United States, Canada and 4 more
- Volunteers
- 129 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Gastrointestinal Diseases, Feeding Intolerance
Evaluation of the Safe Use and Tolerance of a Peptide-based Formula in a Pediatric Population
The objective of this study is to determine the safe use and tolerance of a peptide-based formula in children with gastrointestinal dysfunction and/or feeding intolerance.
- Trial name
- NCT01191112
- Testing
- Peptide based enteral formula
- Where
- Canada
- Volunteers
- 27 people
- Sponsor
- Abbott Nutrition
Gaucher Disease
A Multicenter Extension Study of Taliglucerase Alfa in Pediatric Subjects With Gaucher Disease
A protocol to extend the assessment of the safety and efficacy of taliglucerase alfa in pediatric subjects (2 to <18 years old) with symptoms and clinical manifestations of Gaucher disease who completed treatment in Protocols…
- Trial name
- NCT01411228
- Testing
- Taliglucerase alfa
- Where
- 3 sites in Israel, Paraguay and 1 more
- Volunteers
- 15 people
- Sponsor
- Pfizer
Hypertension
307B - Safety, Tolerability and Pharmacokinetics Study of TOPROL-XL® in Hypertensive Pediatric Subjects
This was a 52-week, multicenter, open-label study to determine the safety, tolerability and pharmacokinetics of TOPROL-XL (metoprolol succinate) extended-release tablets (metoprolol CR/XL) in hypertensive pediatric subjects.
- Trial name
- NCT00255502
- Testing
- metoprolol succinate
- Where
- 31 sites in United States, Dominican Republic
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Pmm2-CDG, Phosphomannomutase 2 Deficiency
24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Participants With PMM2-CDG
This is a Phase 2, randomized, open-label, 24-week treatment study to evaluate the potential pharmacodynamic (PD) activity, safety, tolerability, and pharmacokinetics (PK) of GLM101 in adult, adolescent, and pediatric, patients…
- Trial name
- NCT05549219
- Testing
- GLM101
- Where
- 4 sites in United States, Spain and 1 more
- Volunteers
- 27 people
- Sponsor
- Glycomine, Inc.
Systemic Juvenile Idiopathic Arthritis
Single-dose Study to Assess Efficacy of Canakinumab (ACZ885) in Patients With Active Juvenile Idiopathic Arthritis (SJIA)
This study assessed the initial efficacy and safety of canakinumab over a 4 week period in patients with systemic juvenile idiopathic arthritis (SJIA) having a flare.
- Trial name
- β-SPECIFIC 1 (NCT00886769)
- Testing
- Canakinumab
- Where
- 91 sites in United States, Argentina and 20 more
- Volunteers
- 84 people
- Sponsor
- Novartis Pharmaceuticals
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