Clinical trials: Children, Only
Hepatitis C Virus Infection
Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection
This study will have two parts as follows: The PK Lead-in Phase of the study will evaluate the steady state pharmacokinetics (PK) and confirm the dose of sofosbuvir (SOF) in hepatitis C virus (HCV)-infected pediatric…
- Trial name
- NCT02175758
- Testing
- SOF, RBV
- Where
- 37 sites in United States, Australia and 6 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences
Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome
Assessment of Adjunctive Cannabidiol Oral Solution (GWP42003-P) in Children With Tuberous Sclerosis Complex (TSC), Dravet Syndrome (DS), or Lennox-Gastaut Syndrome (LGS) Who Experience Inadequately-controlled Seizures
This study will be conducted to evaluate the safety, pharmacokinetics (PK), and efficacy of adjunctive GWP42003-P in participants < 2 years of age with tuberous sclerosis complex (TSC), Lennox-Gastaut syndrome (LGS), or Dravet…
- Conditions
- Seizure in Participants With Tuberous Sclerosis Complex, Seizure in Participants With Dravet Syndrome, Seizure in Participants With Lennox-Gastaut Syndrome
- Trial name
- NCT04485104
- Testing
- GWP42003-P
- Where
- 11 sites in United States, Italy and 1 more
- Volunteers
- 3 people
- Sponsor
- Jazz Pharmaceuticals
Acute Myeloid Leukemia (AML), Acute Myeloid Leukemia With FMS-like Tyrosine Kinase 3 (FLT3) Mutation / Internal Tandem Duplication (ITD)
A Study of Gilteritinib (ASP2215) Combined With Chemotherapy in Children, Adolescents and Young Adults With FMS-like Tyrosine Kinase 3 (FLT3)/Internal Tandem Duplication (ITD) Positive Relapsed or Refractory Acute Myeloid Leukemia (AML)
The purpose of the phase 1 portion (dose escalation) of the study was to establish an optimally safe and biologically active recommended phase 2 dose (RP2D) and/or to determine maximum tolerated dose (MTD) for gilteritinib in…
- Trial name
- NCT04240002
- Testing
- gilteritinib, fludarabine, cytarabine
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 9 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Children, Only, Risk Reduction
Reducing Pesticide Exposures in Child Care Centers
A randomized control study was conducted to reduce the exposure to pesticides in child care centers. A 7-month child care health consultant-led integrated pest management (IPM) intervention was conducted in 85 child care centers…
- Conditions
- Children, Only, Risk Reduction, Environmental Exposure
- Trial name
- HCES (NCT03319927)
- Testing
- Changes in pesticide exposure, IPM Practices, Educational Workshops
- Where
- United States
- Volunteers
- 987 people, healthy volunteers welcome
- Sponsor
- University of California, San Francisco
Schizophrenia, Autism
Lurasidone Pediatric Pharmacokinetics Study
This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric…
- Trial name
- NCT01620060
- Testing
- Lurasidone
- Where
- 10 sites in United States
- Volunteers
- 105 people
- Sponsor
- Sumitomo Pharma America, Inc.
Pulmonary Arterial Hypertension
A Study to Assess Whether Macitentan Delays Disease Progression in Children With Pulmonary Arterial Hypertension (PAH)
This is a prospective, multicenter, open-label, randomized, controlled, parallel Phase 3 study with an open-label single-arm extension period to evaluate pharmacokinetics (PK), safety and efficacy of macitentan in children with…
- Trial name
- TOMORROW (NCT02932410)
- Testing
- Macitentan, Standard-of-care
- Where
- 85 sites in United States, Australia and 21 more
- Volunteers
- 165 people
- Sponsor
- Actelion
Influenza
Study Comparing the Immune Response and Safety of Fluarix and Fluzone Influenza Vaccines in Children
The purpose of this study is to compare two influenza vaccines (Fluzone and Fluarix) in terms of the immune response elicited and safety with a six month follow-up after first vaccination.
- Trial name
- NCT00383123
- Testing
- Fluarix™, Fluzone
- Where
- 40 sites in United States
- Volunteers
- 3,327 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Plasmodium Falciparum Infection
To Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of a Single Dose Regimen of Ferroquine and Artefenomel in Adults and Children With Uncomplicated Plasmodium Falciparum Malaria
Primary Objective: To determine whether a single dose combination of OZ439 (Artefenomel)/FQ (Ferroquine) was an efficacious treatment for uncomplicated Plasmodium falciparum malaria in adults and children.
- Trial name
- FALCI (NCT02497612)
- Testing
- Ferroquine SSR97193, Artefenomel
- Where
- 12 sites in Benin, Burkina Faso and 5 more
- Volunteers
- 377 people
- Sponsor
- Sanofi
Neoplasm Metastasis
A Study of Olaratumab Alone and in Combination With Standard Chemotherapies in Children With Cancer
The main purpose of this study is to evaluate the safety of different doses of olaratumab and to determine which dose should be used for future pediatric studies.
- Trial name
- NCT02677116
- Testing
- Olaratumab, Doxorubicin, Vincristine
- Where
- 21 sites in United States, Japan
- Volunteers
- 68 people
- Sponsor
- Eli Lilly and Company
Attention Deficit Hyperactivity Disorder
Efficacy of GXR as Adjunctive Therapy With Psycho-stimulant on Executive Function in Children With ADHD
This study looks to examine whether or not INTUNIV extended release can help children aged 6-12 years diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) in improving Executive Function when added to their usual care…
- Trial name
- NCT01985581
- Testing
- Guanfacine extended release, Stimulant therapy
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- JPM van Stralen Medicine Professional
Attention-Deficit Hyperactivity Disorder
Pharmacokinetics of HLD200 in Children and Adolescents With ADHD
This study was designed to assess the pharmacokinetic effects of a single dose of HLD200 (methylphenidate hydrochloride) in children and adolescents with ADHD.
- Trial name
- NCT01907360
- Testing
- HLD200 (methylphenidate hydrochloride)
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Ironshore Pharmaceuticals and Development, Inc
Hypertension
Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
The purpose of this extension study is to compare the long-term safety of valsartan versus enalapril, and the effectiveness of the combination of valsartan and enalapril versus enalapril alone in children with hypertension.
- Trial name
- NCT00446511
- Testing
- Valsartan, Enalapril
- Where
- 9 sites in United States, Belgium and 7 more
- Volunteers
- 250 people
- Sponsor
- Novartis Pharmaceuticals
Dental Pain
Buffered Local Anesthetic
The purpose of this research study is to compare responses in children during dental injections of local anesthetic (used for numbing), while children are under deep sedation (breathing on their own, often with a loss of…
- Trial name
- NCT05757648
- Testing
- Non-buffered Anesthetic, Buffered Anesthetic, Onset
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Appendicitis, Children
Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis (Antibiotics Alone vs. Appendectomy)
The purpose of this study is to determine if a patient activation tool (PAT) can improve decision making and patient centered outcomes in pediatric patients with appendicitis and their caregivers choosing between antibiotics…
- Trial name
- Appy-PAT (NCT02110485)
- Testing
- Patient Activation Tool
- Where
- United States
- Volunteers
- 200 people
- Sponsor
- Peter Minneci
Influenza
A Randomized, Controlled Trial on the Efficacy and Safety of Live-Attenuated Influenza Vaccine (LAIV) Among Children in Bangladesh
This is a single center, multi-site, double-blind, parallel group, placebo-controlled trial of the clinical efficacy of trivalent Serum Institute of India, Ltd.
- Trial name
- NCT01797029
- Testing
- SIIL Live Attenuated Influenza Vaccine
- Where
- 2 sites in Bangladesh
- Volunteers
- 1,761 people, healthy volunteers welcome
- Sponsor
- PATH
Epilepsy
Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With Epilepsy
Keppra injection is approved in the US as adjunctive therapy in the treatment of partial onset seizures in adults with epilepsy.
- Trial name
- NCT00535392
- Testing
- Levetiracetam
- Where
- 25 sites in United States, Belgium and 4 more
- Volunteers
- 33 people
- Sponsor
- UCB Pharma
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
Sleep Apnea, Obstructive, Hypotonia
Pilot Study of a Self-Supporting Nasopharyngeal Airway in Hypotonia
Children with hypotonic upper airway obstruction have a high prevalence of severe obstructive sleep apnea, which if not treated has significant clinical consequence.
- Conditions
- Sleep Apnea, Obstructive, Hypotonia, Child, Only
- Trial name
- ssNPA (NCT04846400)
- Testing
- ssNPA
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University of Michigan
Juvenile Rheumatoid Arthritis
Etanercept Plus Methotrexate Versus Methotrexate Alone in Children With Polyarticular Course Juvenile Rheumatoid Arthritis
The primary objective of this study was to determine the efficacy of etanercept plus methotrexate vs methotrexate alone in pediatric patients with active polyarticular course juvenile rheumatoid arthritis (JRA).
- Trial name
- NCT03781375
- Testing
- Etanercept, Methotrexate
- Volunteers
- 25 people
- Sponsor
- Amgen
Hepatic Insufficiency, Healthy
Pharmacokinetics of Empagliflozin (BI 10773) in Patients With Impaired Liver Function
The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.
- Trial name
- NCT01111318
- Testing
- BI 10773
- Where
- Romania
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim