Clinical trials: Pediatric Disease
Congenital Heart Disease
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair.
- Trial name
- TORCH-LATAM (NCT07799272)
- Testing
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Volunteers
- 600 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Myopia
Pivotal Study of SAT-001 in Treatment of Pediatric Patient With Myopia
The objective of this clinical investigation is to evaluate the efficacy and safety of SAT-001 designed as Software as Medical Device (SaMD) for slowing myopia progression and treatment in pediatric myopia patients.
- Trial name
- NCT06344572
- Testing
- SAT-001, Single vision spectacles
- Where
- South Korea
- Volunteers
- 110 people
- Sponsor
- S-Alpha Therapeutics, Inc.
Sickle Cell Disease
Expanded Access Protocol for Adults and Pediatric Patients With Sickle Cell Disease Who Have No Alternative Treatment Options
The objective of this Expanded Access Protocol (EAP) is to provide voxelotor for the treatment of sickle cell disease (SCD): The study GBT440-041 is the EAP for pediatric patients aged 6 months to 11 years who have no alternative…
- Trial name
- NCT04724421
- Testing
- Voxelotor
- Where
- 37 sites in United States, Brazil
- Sponsor
- Pfizer
Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial
Observation of Side Effects and Effectiveness of Desloratadine (Aerius) Syrup in Filipino Children (Study P05634)
The purpose of this study is to observe the side effects of desloratadine syrup and how effective it is in relieving symptoms of allergic rhinitis or hives in Filipino children.
- Conditions
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic, Perennial, Urticaria
- Trial name
- NCT00761527
- Testing
- Desloratadine Syrup
- Volunteers
- 2,980 people
- Sponsor
- Organon and Co
Generalized Myasthenia Gravis, gMG
PK, PD, Safety, and Efficacy Study of Gefurulimab in Pediatric Patients With AChR+ Generalized Myasthenia Gravis
The primary objective of this study is to assess the pharmacokinetics and pharmacodynamics of gefurulimab in pediatric participants with AChR+ gMG for the duration of the study.
- Trial name
- NCT06607627
- Testing
- Gefurulimab
- Where
- 13 sites in United States, Brazil and 3 more
- Volunteers
- 12 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Esophageal Atresia, Digestive System Abnormalities
Flourish™ Pediatric Esophageal Atresia
This study is continued evaluation of the safety and probable benefit of the Flourish Pediatric Esophageal Atresia device through the Humanitarian Device Exemption (HDE) pathway.
- Conditions
- Esophageal Atresia, Digestive System Abnormalities, Esophageal Disorders Congenital
- Trial name
- NCT03615495
- Testing
- Flourish Pediatric Esphogeal Atresia device
- Where
- 12 sites in United States, Canada
- Volunteers
- 21 people
- Sponsor
- Cook Research Incorporated
Myopia, Progressive
Efficacy of IVMED-85 on Pediatric Myopia
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of a 1-year course of IVMED-85 eye drops for the treatment of pediatric myopia by assessing its safety effects on visual acuity and its effect on…
- Trial name
- NCT05761795
- Testing
- IVMED 85
- Volunteers
- 216 people
- Sponsor
- iVeena Delivery Systems, Inc.
Ulcerative Colitis
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
- Trial name
- NCT00336492
- Testing
- infliximab
- Where
- 27 sites in United States, Belgium and 3 more
- Volunteers
- 60 people
- Sponsor
- Centocor, Inc.
Migraine
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to <12 years) and adolescents (12 to <18 years) with chronic migraine.
- Trial name
- OASIS(CM) (NCT03832998)
- Testing
- Erenumab Dose 1, Erenumab Dose 2, Erenumab Dose 3
- Where
- 101 sites in United States, Belgium and 11 more
- Volunteers
- 284 people
- Sponsor
- Amgen
Melanoma
A Study to Evaluate Treatment With Nivolumab Alone and Nivolumab Combined With Ipilimumab in Children With Melanoma
The purpose of this study is to describe real-world safety outcomes in children with melanoma who are treated with nivolumab alone or nivolumab in combination with ipilimumab for unresectable or metastatic melanoma, or treated…
- Trial name
- NCT06163170
- Testing
- Nivolumab +/- ipilimumab, Nivolumab
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Bristol-Myers Squibb
Central Nervous System Diseases, Central Nervous System Neoplasms
Evaluation of Safety and Efficacy of ProHance in Pediatric Patients <2yrs
Safety and Efficacy Study in pediatric subjects <2 years of age who have undergone Brain or Spine MRI pre and post 0.1 mmol/kg ProHance administration. Imaging conditions will represent those in routine clinical practice.
- Trial name
- NCT03750188
- Testing
- ProHance
- Where
- United States
- Volunteers
- 125 people
- Sponsor
- Bracco Diagnostics, Inc
Enterovirus Infections
A Study to Evaluate the Immunogenicity and Safety of EV71 Vaccine in Pediatric Subjects
The objectives of this study are to evaluate the immune response and safety profiles of two injections of EV71 vaccine administrated with or without adjuvant Al(OH)3 at 0.5-μg and 1-μg dose in children aged 3 to 6 years old and 2…
- Trial name
- NCT03268083
- Testing
- EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein + adjuvant 150 μg AI(OH)3] per dose), EV71 vaccine ([1 μg total protein ] per dose)
- Where
- 4 sites in Taiwan
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Enimmune Corporation
Pandemic H5N1 Influenza
Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Children
Evaluate Safety, Tolerability and Immune response of adjuvanted H5N1 cell culture derived influenza vaccine in children.
- Trial name
- NCT01776554
- Testing
- Adjuvanted H5N1 pandemic influenza vaccine
- Where
- 12 sites in United States, Thailand
- Volunteers
- 662 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Psoriasis
Post-Marketing Surveillance Study of Adalimumab in Pediatric Chronic Severe Plaque Psoriasis Patients in Korea
The objective of this study is to evaluate the real world safety and effectiveness of adalimumab (Humira) for the treatment of Korean patients with pediatric chronic severe plaque psoriasis under a routine treatment practice.
- Trial name
- ped PsO rPMS (NCT03925441)
- Where
- South Korea
- Volunteers
- 2 people
- Sponsor
- AbbVie
Diphtheria, Pertussis
Study of PR5I, a Pediatric Combination Vaccine With Enhanced Hepatitis B Component Given Concomitantly With Prevnar®
PR5I, a hexavalent pediatric combination vaccine is being developed to reduce the number of injections during the first 2 years of life while providing a complete course of immunization against infection caused by H.
- Conditions
- Diphtheria, Pertussis, Polio, Hepatitis B
- Trial name
- NCT00362427
- Testing
- Hybrid 5 component DTaP, Vero IPV, Hep B and PRP-OMPC
- Where
- 8 sites in Canada
- Volunteers
- 460 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Psoriasis
A Study of Subcutaneous Risankizumab Injection for Pediatric Participants With Moderate to Severe Plaque Psoriasis to Assess Change in Disease Symptoms
Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin.
- Trial name
- OptIMMize-1 (NCT04435600)
- Testing
- Risankizumab, Ustekinumab
- Where
- 53 sites in United States, Canada and 5 more
- Volunteers
- 139 people
- Sponsor
- AbbVie
Obesity
A Single Dose Pharmacokinetic Study of Lorcaserin Hydrochloride in Obese Pediatric Subjects 6 to 11 Years of Age
Study will evaluate the pharmacokinetics (PK), safety and tolerability of a single 10 mg dose of lorcaserin hydrochloride in obese pediatric subjects 6 to 11 years of age.
- Trial name
- NCT02398669
- Testing
- Lorcaserin hydrochloride
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Eisai Inc.
Bipolar I Disorder
The Young Adult and Pediatric Bipolar Study
To examine the safety and effectiveness of extended-release carbamazepine in the treatment of children and adolescents aged 10-17 years with acute manic or mixed bipolar I disorder.
- Trial name
- NCT00350857
- Testing
- Extended-Release Carbamazepine
- Where
- 26 sites in United States
- Volunteers
- 161 people
- Sponsor
- Validus Pharmaceuticals
Generalized Myasthenia Gravis
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
The purpose of the study is to assess the long term safety and tolerability of additional 6-week treatment cycles with rozanolixizumab in pediatric participants with generalized Myasthenia Gravis (gMG) aged ≥2 at the time of the…
- Trial name
- NCT06540144
- Testing
- rozanolixizumab
- Where
- 9 sites in Italy, Japan and 2 more
- Volunteers
- 13 people
- Sponsor
- UCB Biopharma SRL
Juvenile Idiopathic Arthritis
Efficacy Study Of Tofacitinib In Pediatric JIA Population
Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.
- Trial name
- NCT02592434
- Testing
- CP-690,550 (tofacitinib)
- Where
- 103 sites in United States, Argentina and 12 more
- Volunteers
- 225 people
- Sponsor
- Pfizer
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