Clinical trials: Pediatric Disease
Bipolar Disorder, Affective Disorders, Psychotic
A Study to Evaluate the Safety and Effectiveness of Topiramate Compared to Placebo in the Treatment of Patients With Bipolar I Disorder
The purpose of this study is to determine the safety and efficacy of topiramate in adolescents with manic or mixed episodes of Bipolar I Disorder.
- Conditions
- Bipolar Disorder, Affective Disorders, Psychotic, Mood Disorders, Mental Disorders
- Trial name
- NCT00035802
- Testing
- Topiramate
- Volunteers
- 13 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Meningococcal Immunization, Healthy Volunteers
Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants
This study is the first study of Sanofi's Pentavalent Meningococcal ABCYW vaccine clinical development program to be conducted in the pediatric population below 10 years of age.
- Trial name
- NCT06647407
- Testing
- Pentavalent Meningococcal ABCYW vaccine, MenACYW conjugate vaccine, Meningococcal group B vaccine
- Where
- 39 sites in Brazil, Czechia and 7 more
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Leukemia
A Phase II Study of Dasatinib in Children and Adolescents With Newly Diagnosed Chronic Phase Chronic Myelogenous Leukemia (CML) or With Ph+ Leukemias Resistant or Intolerant to Imatinib
The purpose of this study is to determine whether dasatinib is safe and effective in children and adolescents with newly diagnosed chronic myeloid leukemia (CML), or in children with Ph+ acute lymphoblastic leukemia (ALL)…
- Trial name
- NCT00777036
- Testing
- Dasatinib
- Where
- 174 sites in United States, Argentina and 16 more
- Volunteers
- 133 people
- Sponsor
- Bristol-Myers Squibb
Anemia Associated With Chronic Kidney Disease
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
This open-labeled, multicenter study is designed to evaluate the efficacy, safety and PK/PD of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5, as well as end-stage renal disease (ESRD) who…
- Trial name
- NCT04621331
- Testing
- Roxadustat
- Where
- 4 sites in United States
- Sponsor
- Kyntra Bio
Primary Immune Thrombocytopenia (ITP)
A Study of Ianalumab in Addition to Eltrombopag in Pediatric Patients With Primary ITP Who Failed Corticosteroids.
The purpose of this study is to assess the efficacy, safety and pharmacokinetics (PK) of ianalumab (VAY736) in addition to eltrombopag treatment; and to inform the dose of ianalumab in pediatric patients (5 to <18 years of age)…
- Trial name
- VAYHIT-P (NCT07660172)
- Testing
- Ianalumab, Eltrombopag
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Sickle Cell Disease
A Study to Evaluate the Pharmacokinetics and Safety of Etavopivat in Pediatric Patients With Sickle Cell Disease
The purpose of this study is to evaluate the pharmacokinetics and safety of etavopivat in paediatric participants with sickle cell disease (SCD).
- Trial name
- HIBISCUS KIDS (NCT06198712)
- Testing
- Etavopivat
- Where
- 18 sites in Canada, France and 5 more
- Volunteers
- 95 people
- Sponsor
- Forma Therapeutics, Inc.
Attention Deficit Hyperactivity Disorder
Dasotraline Pediatric Extension Study
This is an open label 26 week extension study for subjects who completed SEP360-202.
- Trial name
- NCT02457819
- Testing
- Dasotraline
- Where
- 36 sites in United States
- Volunteers
- 237 people
- Sponsor
- Sumitomo Pharma America, Inc.
Severe Alopecia Areata
A Study to Evaluate the Safety and Effectiveness of Upadacitinib in Pediatric Participants With Alopecia Areata
Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the scalp and face, but hair loss can happen on any hair-bearing part of the body.
- Trial name
- NCT07772492
- Testing
- Upadacitinib
- Where
- 14 sites in United States, Australia and 2 more
- Volunteers
- 300 people
- Sponsor
- AbbVie
Acute Leukemia, Myelodysplastic Syndrome
Study of QUAIL-100 in Pediatric and Young Adult Participants With High-Risk Hematologic Malignancies Who Have Received a Hematopoietic Stem Cell Transplantation
Study of QUAIL-100 in Patients With High Risk Acute Leukemia and Myelodysplastic Syndrome Who Have Received Hematopoietic Stem Cell Transplant
- Trial name
- NCT07573111
- Testing
- QUAIL-100
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Laguna Biotherapeutics, Inc.
Congenital Adrenal Hyperplasia, Classic Congenital Adrenal Hyperplasia
A Study in Pediatric Participants With Congenital Adrenal Hyperplasia (Balance-CAH)
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of atumelnant treatment in pediatric participants with classic congenital adrenal hyperplasia (CAH).
- Trial name
- NCT07159841
- Testing
- Atumelnant
- Where
- 51 sites in United States, Argentina and 11 more
- Volunteers
- 153 people
- Sponsor
- Crinetics Pharmaceuticals Inc.
Asthma
A Safety and Efficacy Study of Beclomethasone Dipropionate Delivered Via Breath-Actuated Inhaler (BAI) or Metered-Dose Inhaler (MDI) in Participants Ages 4-11 Years Old With Persistent Asthma
This randomized, double-blind, double-dummy, placebo-controlled, parallel-group, 12-week study will evaluate the efficacy and safety of beclomethasone dipropionate (80 or 160 mcg/day) administered via breath-actuated inhaler…
- Trial name
- NCT02040766
- Testing
- Beclomethasone dipropionate BAI, albuterol/salbutamol 90 mcg, Beclomethasone dipropionate MDI
- Where
- 102 sites in United States, Croatia and 3 more
- Volunteers
- 628 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Major Depressive Disorder
Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).
- Trial name
- NCT03569475
- Testing
- Levomilnacipran ER, Fluoxetine
- Where
- 51 sites in United States
- Volunteers
- 501 people
- Sponsor
- Allergan
Psoriasis Vulgaris, Psoriatic Arthritis
Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP
This was a multicenter, centrally registered observational study without a control group. This observational study was a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during…
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Pustular Psoriasis
- Trial name
- NCT05215561
- Testing
- Cosentyx
- Where
- 21 sites in Japan
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Acquired Immune Deficiency Syndrome (AIDS), HIV Infections
Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
The goal of this clinical study is to learn more about the safety and dosing of study drugs, cobicistat-boosted Atazanavir (ATV/co), cobicistat-boosted darunavir (DRV/co) and emtricitabine/tenofovir alafenamide (F/TAF), in…
- Trial name
- NCT02016924
- Testing
- ATV, DRV, Cobicistat
- Where
- 23 sites in United States, Argentina and 5 more
- Volunteers
- 133 people
- Sponsor
- Gilead Sciences
Myopia
Exploratory Study on the Effect of SAT-001 on Choroidal Thickness in Pediatric Myopia Patients
This clinical trial aims to exploratively compare and evaluate the structural changes in the eye (specifically changes in choroidal thickness) pre- and post-treatment of the investigational medical devices ('SAT-001' and…
- Trial name
- NCT06729723
- Testing
- SAT-001, modified SAT-001
- Where
- 2 sites in South Korea
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- S-Alpha Therapeutics, Inc.
Growth Disorders
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in Italy
This is an Italian, Multicentre, Observational Study to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using easypod™ electromechanical device for growth hormone treatment to assess the level of…
- Trial name
- ECOS ITA (NCT01439061)
- Testing
- Device: easypod™
- Where
- Italy
- Volunteers
- 220 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Cytomegalovirus Infections, Heart Transplantation
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.
- Trial name
- NCT01165580
- Testing
- valganciclovir [Valcyte]
- Where
- 19 sites in United States, Canada and 1 more
- Volunteers
- 17 people
- Sponsor
- Hoffmann-La Roche
Progressive Familial Intrahepatic Cholestasis
Odevixibat for the Treatment of Progressive Familial Intrahepatic Cholestasis
To provide treatment access to patients with PFIC in the US who have pruritus and elevated serum bile acids and who are not able to enroll in A4250-008 (PEDFIC2) for the following reasons: 1) Do not meet eligibility criteria for…
- Trial name
- NCT04483531
- Testing
- Odevixibat
- Where
- United States
- Sponsor
- Albireo
Cartilage Disease
Non-interventional Study in Pediatric Patients Treated With NOVOCART Inject in the Knee
The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee in pediatric patients with…
- Trial name
- NINJA (NCT05391841)
- Testing
- NOVOCART Inject
- Where
- 6 sites in Germany
- Sponsor
- Tetec AG
Juvenile Idiopathic Arthritis
Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)
Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less than 18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).
- Trial name
- NCT01513902
- Testing
- CP-690,550
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 26 people
- Sponsor
- Pfizer
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