Clinical trials: Pediatric
Invasive Fungal Infection
Posaconazole (MK-5592) Intravenous and Oral in Children (<2 Years) With Invasive Fungal Infection (MK-5592-127)
This study aims to estimate the pharmacokinetics (PK) of posaconazole (POS, MK-5592) intravenous (IV) and powder for oral suspension (PFS) formulations in pediatric participants <2 years of age with invasive fungal infection…
- Trial name
- NCT04665037
- Testing
- Posaconazole IV 6 mg/kg, Posaconazole PFS 6 mg/kg
- Where
- 26 sites in United States, Belgium and 8 more
- Volunteers
- 40 people
- Sponsor
- Merck Sharp & Dohme LLC
Menorrhagia
Lysteda Pediatric Research Equity Act (PREA) Pharmacokinetic Study in Adolescent Females With Heavy Menstrual Bleeding
This is a Phase 4, randomized, 2-way crossover, pharmacokinetic study of Lysteda (tranexamic acid) tablets administered as single doses of 0.65 g and 1.3 g in fasting adolescent female subjects ages 12-16 years with heavy…
- Trial name
- PREA (NCT01190150)
- Testing
- tranexamic acid
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Ferring Pharmaceuticals
Moderate/Severe Atopic Dermatitis
Preventive Treatment of Tacrolimus Ointment in Children With Atopic Dermatitis
To assess if proactive, 2 times-weekly application of tacrolimus ointment can extend remission time to relapse and reduce the incidence of disease exacerbation (DE) in paediatric patients over a period of 6 months.
- Trial name
- NCT01745159
- Testing
- tacrolimus
- Where
- 4 sites in China
- Volunteers
- 125 people
- Sponsor
- Astellas Pharma China, Inc.
Burns
Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours…
- Trial name
- NCT00606489
- Testing
- Caldolor
- Where
- 5 sites in United States, India
- Volunteers
- 61 people
- Sponsor
- Cumberland Pharmaceuticals
Duchenne Muscular Dystrophy
A Gene Transfer Therapy Study to Evaluate the Safety and Efficacy of Delandistrogene Moxeparvovec (SRP-9001) Following Imlifidase Infusion in Participants With Duchenne Muscular Dystrophy (DMD) Determined to Have Pre-existing Antibodies to Recombinant Adeno-Associated Virus Serotype (rAAVrh74)
This is a gene transfer therapy study evaluating the safety of delandistrogene moxeparvovec and delandistrogene moxeparvovec dystrophin expression in association with imlifidase, in participants with DMD with pre-existing…
- Trial name
- NCT06241950
- Testing
- delandistrogene moxeparvovec, imlifidase
- Where
- Spain
- Volunteers
- 5 people
- Sponsor
- Sarepta Therapeutics, Inc.
Urea Cycle Disorder
A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders
This is an open-label study consisting of a transition period to RAVICTI, followed by a safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI, depending on age at enrollment.
- Trial name
- NCT02246218
- Testing
- RAVICTI
- Where
- 17 sites in United States, Canada
- Volunteers
- 27 people
- Sponsor
- Amgen
Infectious Diseases
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such…
- Trial name
- NCT00761462
- Testing
- Ciprofloxacin, Non-quinolone antibiotic
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,029 people
- Sponsor
- Bayer
Type 1 Diabetes
The MiniMed™ 780G Glycemic Control and Quality of Life Study for the Treatment of Pediatric and Adult Subjects With Type 1 Diabetes in France.
The purpose of the study is to evaluate the efficacy in glycemic control and the impact on the quality of life of patients using the MiniMed™ 780G System for the treatment of Type 1 diabetes, in real life settings in France.
- Trial name
- NCT04308291
- Testing
- MiniMed™ 780G System
- Where
- 32 sites in France
- Volunteers
- 306 people
- Sponsor
- Medtronic MiniMed, 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.
Healthy
Normative Oculomotor and Vestibular Data in Pediatric Population
The purpose of this study is to use a device called I-Portal® Portable Assessment System (I-PAS) to record eye movements in response to a number of visual and auditory stimuli designed to evaluate neural brain pathways related to…
- Trial name
- NCT04107610
- Testing
- I-PAS
- Where
- 2 sites in United States
- Volunteers
- 600 people, healthy volunteers welcome
- Sponsor
- Neurolign
Diabetes Mellitus, Type 2
Phase 3 Alogliptin Pediatric Study
The primary purpose of this study is to evaluate the efficacy of alogliptin 25 milligram (mg) once daily compared to placebo when administered as monotherapy, or when added onto a background of metformin alone, insulin alone, or…
- Trial name
- NCT02856113
- Testing
- Alogliptin Benzoate
- Where
- 67 sites in United States, Brazil and 5 more
- Volunteers
- 152 people
- Sponsor
- Takeda
B-Cell Pediatric ALL
Study in Pediatrics With Relapsed or Refractory Pediatric Acute Lymphoblastic Leukemia (pALL) or Lymphoblastic Lymphoma
The primary objective of this study is to evaluate the efficacy of moxetumomab pasudotox in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL) or B-cell lymphoblastic lymphoma.
- Trial name
- NCT02227108
- Testing
- Moxetumomab Pasudotox
- Where
- 21 sites in United States, Australia and 6 more
- Volunteers
- 37 people
- Sponsor
- MedImmune LLC
Schizophrenia, Bipolar Disorder
A Study to Evaluate the Safety and the Effects of Risperidone Compared With Other Atypical Antipsychotic Drugs on the Growth and Sexual Maturation in Children
The purpose of this study is to evaluate the effects of risperidone compared with other atypical antipsychotic drugs on the physical maturity, growth and development of children, and the risk of prolactin-related adverse events…
- Conditions
- Schizophrenia, Bipolar Disorder, Autistic Disorder, Conduct and Other Disruptive Behavior Disorders
- Trial name
- NCT01050582
- Testing
- Risperidone, Other atypical antipsychotic drugs
- Where
- 28 sites in United States, Belgium and 4 more
- Volunteers
- 244 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Dental Caries
Trial of a New NuSmile ZR Esthetic Primary Molar Crown
The hypothesis to be tested is that NuSmile ZR esthetic primary molar crowns perform similarly to an established Stainless Steel primary molar crown (3M ESPE) for restoration of primary molar teeth.
- Trial name
- NCT01919515
- Testing
- ZR Crown, Stainless Steel Crown
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- NuSmile, Ltd.
Influenza
Safety and Immunogenicity of A/H1N1-SOIV (Swine Flu) Vaccine With and Without Adjuvant in Children (3 to < 9 Years)
This study will evaluate the safety and immunogenicity of different combinations of A/H1N1 S-OIV (swine flu) vaccine in healthy young children.
- Trial name
- NCT00972816
- Testing
- MF59-eH1N1
- Where
- 35 sites in United States, Mexico
- Volunteers
- 1,357 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
PIK3CA-related Overgrowth Spectrum (PROS)
Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)
This Phase II, multicenter, open-label study, preceded by a retrospective non-interventional period, is assessing the long-term safety and efficacy of alpelisib in pediatric and adult participants with PIK3CA-related overgrowth…
- Trial name
- EPIK-P3 (NCT04980833)
- Testing
- Alpelisib
- Where
- 6 sites in United States, France and 2 more
- Volunteers
- 41 people
- Sponsor
- Novartis Pharmaceuticals
Hereditary Angioedema
A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
The main aims of this study are to learn how lanadelumab moves through a child's body and if the children have any medical problems from lanadelumab.
- Trial name
- SPRING (NCT04070326)
- Testing
- Lanadelumab
- Where
- 17 sites in United States, Canada and 3 more
- Volunteers
- 21 people
- Sponsor
- Shire
Sickle Cell Disease
Study to Evaluate the Effect of GBT440 in Pediatrics With Sickle Cell Disease
This study consists of four parts, Parts A, B, C, and D. Part A is a single dose pharmacokinetic (PK) study in pediatric participants with Sickle Cell Disease ages 6 to 17 years.
- Trial name
- HOPE-KIDS (NCT02850406)
- Testing
- Voxelotor
- Where
- 20 sites in United States, Lebanon and 1 more
- Volunteers
- 147 people
- Sponsor
- Pfizer
Gaucher's Disease Type III
Study to Evaluate the Efficacy and Safety of Venglustat in Adult and Pediatric Patients With Gaucher Disease Type 3
This is a parallel arm, Phase 3, double-blind, double-dummy, active-comparator, 2 arm study to evaluate the efficacy and safety of daily oral venglustat versus intravenous Cerezyme infusions every two weeks for improvement or…
- Trial name
- LEAP2MONO (NCT05222906)
- Testing
- Venglustat, imiglucerase
- Where
- 22 sites in United States, Argentina and 9 more
- Volunteers
- 43 people
- Sponsor
- Sanofi
Oesophagitis, Eosinophilic
Intravenous Mepolizumab In Children With Eosinophilic Esophagitis
This study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab in pediatric subjects with eosinophilic esophagitis.
- Trial name
- NCT00358449
- Testing
- mepolizumab
- Where
- 29 sites in United States, Australia and 2 more
- Volunteers
- 84 people
- Sponsor
- GlaxoSmithKline