Clinical trials: Pediatric Safety and Effectiveness
Malignant Rhabdoid Tumors (MRT), Neuroblastoma
Study of Safety and Efficacy in Patients With Malignant Rhabdoid Tumors (MRT) and Neuroblastoma
LEE011 is a small molecule inhibitor of CDK4/6. LEE011 has demonstrated in vitro and in vivo activity in both tumor models. The primary purpose of this study was to determine the maximum tolerated dose (MTD) and/or recommended…
- Trial name
- NCT01747876
- Testing
- LEE011
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 32 people
- Sponsor
- Novartis Pharmaceuticals
FLT3-mutated Acute Myeloid Leukemia
A Global Study of Midostaurin in Combination With Chemotherapy to Evaluate Safety, Efficacy and Pharmacokinetics in Newly Diagnosed Pediatric Patients With FLT3 Mutated AML
This study will evaluate the safety, efficacy and pharmacokinetics of midostaurin in combination with standard chemotherapy in pediatrics patients with newly diagnosed FLT3-mutated Acute Myeloid Leukemia.
- Trial name
- NCT03591510
- Testing
- Midostaurin, Fludarabine, Cytarabine
- Where
- 15 sites in Czechia, Germany and 8 more
- Volunteers
- 22 people
- Sponsor
- Novartis Pharmaceuticals
Generalized Convulsive Epilepsy
Study to Evaluate the Safety and Efficacy of Levetiracetam in Patients Suffering From Idiopathic Generalized Epilepsy With Primary Generalized Tonic-clonic Seizures
This study will assess the efficacy, safety, and tolerability of adjunctive treatment with LEV (3,000 mg/day or a target dose of 60 mg/kg/day in children) compared to placebo in reducing PGTC seizures in subjects (4 - 65 years)…
- Trial name
- NCT00160550
- Testing
- Levetiracetam
- Volunteers
- 154 people
- Sponsor
- UCB Pharma
CHARGE Syndrome
A Strategic Approach to Safe and Effective Cochlear Implantation in Patients With CHARGE Syndrome
This retrospective observational study aims to evaluate cochlear anatomy, surgical challenges, and strategic approaches for safe cochlear implantation in pediatric patients with CHARGE syndrome.
- Trial name
- NCT07320482
- Testing
- No intervention (observational study)
- Where
- South Korea
- Volunteers
- 12 people
- Sponsor
- Seoul National University Bundang Hospital
Heterozygous Familial Hypercholesterolemia
Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders
A study to assess safety and efficacy of evolocumab (AMG-145) in paediatric subjects aged 10-17 years diagnosed with heterozygous familial hypercholesterolemia.
- Trial name
- HAUSER-RCT (NCT02392559)
- Testing
- Evolocumab
- Where
- 66 sites in United States, Australia and 24 more
- Volunteers
- 158 people
- Sponsor
- Amgen
Iron Deficiency Anemia
Multicenter Randomized Active-controlled Study to Investigate Efficacy & Safety of IV FCM in Pediatric Patients With IDA
The primary objective of this study is to demonstrate the efficacy and safety of intravenous ferric carboxymaltose (FCM), compared to oral iron, in pediatric participants who have iron deficiency anemia.
- Trial name
- NCT03523117
- Testing
- Ferric carboxymaltose, Ferrous Sulfate
- Where
- 16 sites in United States
- Volunteers
- 79 people
- Sponsor
- American Regent, Inc.
Vitamin A Deficiency, Pediatric
Efficacy and Safety of Vitamin A Treatment for Children With Sepsis
The prevalence of vitamin A deficiency was found high in children with sepsis. Whether those patients will benefit from the vitamin A supplementation is unknown.
- Conditions
- Vitamin A Deficiency, Pediatric, Sepsis
- Trial name
- NCT04127968
- Testing
- Vitamin A, Oil
- Volunteers
- 450 people
- Sponsor
- West China Hospital
Transfusional Iron Overload, Beta-Thalassemia
Safety, Efficacy and Pharmacokinetics of an Oral Iron Chelator Given for a Year to Pediatric Patients With Iron Overload
This is an open-label study to assess the pharmacokinetics, safety, efficacy and tolerability of SSP-004184AQ. The study consists of two phases: the pharmacokinetic phase, using a single 16 mg/kg dose of SSP-004184AQ; and the…
- Trial name
- NCT01363908
- Testing
- SPD602
- Where
- 9 sites in United States, Canada and 3 more
- Volunteers
- 30 people
- Sponsor
- Shire
Narcolepsy, Sleep Apnea, Obstructive
PROVIGIL® (Modafinil) Treatment in Children and Adolescents With Excessive Sleepiness Associated With Narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome
The primary objective of the study is to evaluate the safety and tolerability of treatment with PROVIGIL in children and adolescents with excessive sleepiness (ES) associated with narcolepsy or OSAHS (obstructive sleep…
- Trial name
- NCT00107848
- Testing
- Modafinil
- Where
- 61 sites in United States, Canada
- Volunteers
- 280 people, healthy volunteers welcome
- Sponsor
- Cephalon
Tracheobronchomalacia
Bioresorbable Airway Splint Pivotal Clinical Trial
The purpose of this study is to learn if a three-dimensional (3D) printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia (TBM) in children.
- Trial name
- NCT06406452
- Testing
- Bioresorbable Tracheobronchial Splint
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- University of Michigan
Pediatric Recurrent/Refractory BRAFV600E-mutant Gliomas
Vemurafenib in Children With Recurrent/Refractory BRAF Gene V600E (BRAFV600E)-Mutant Gliomas
This is a multicenter, safety and pharmacokinetic trial to determine the MTD and/or select a recommended phase 2 dose (RP2D) of vemurafenib in children with recurrent or refractory gliomas containing the BRAFV600E or BRAF Ins T…
- Trial name
- NCT01748149
- Testing
- Vemurafenib
- Where
- 21 sites in United States, Canada
- Volunteers
- 40 people
- Sponsor
- University of California, San Francisco
Rhinitis, Allergic, Perennial
Fexofenadine Study On Filipino Children for The Relief of Perennial And Intermittent Allergic Rhinitis
To determine the safety and efficacy of Fexofenadine (Telfast®) 30mg pediatric tablets on Filipino children aged 6 to 11 for the relief of symptoms associated with perennial and intermittent allergic rhinitis.
- Trial name
- NCT00741897
- Testing
- Fexofenadine
- Where
- Philippines
- Volunteers
- 264 people
- Sponsor
- Sanofi
Systemic Lupus Erythematosus
An Efficacy and Safety Study of Intravenous Anifrolumab to Treat Systemic Lupus Erythematosus in Pediatric Participants
A Study to Evaluate the Pharmacokinetics (PK), Pharmacodynamics (PD), Efficacy, and Safety of Anifrolumab in Children with Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
- Trial name
- BLOSSOM (NCT05835310)
- Testing
- Anifrolumab
- Where
- 103 sites in United States, Argentina and 15 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Progressive Familial Intrahepatic Cholestasis (PFIC)
Open Label Study to Evaluate Efficacy and Long Term Safety of LUM001 (Maralixibat) in the Treatment of Cholestatic Liver Disease in Patients With Progressive Familial Intrahepatic Cholestasis
This is an open label study in children with Progressive Familial Intrahepatic Cholestasis (PFIC) designed to evaluate the safety and efficacy of LUM001, also known as Maralixibat (MRX).
- Trial name
- INDIGO (NCT02057718)
- Testing
- LUM001 (Maralixibat)
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 33 people
- Sponsor
- Mirum Pharmaceuticals, Inc.
Irritability Associated With Autism Spectrum Disorder
Multicenter Study of Lumateperone for the Treatment of Irritability Associated With Autism Spectrum Disorder in Pediatric Patients
This is a multicenter, randomized, double-blind, placebo-controlled study in pediatric patients aged 5 to 17 years with a primary diagnosis of irritability associated with Autism Spectrum Disorder (ASD) based on Diagnostic and…
- Trial name
- NCT06690398
- Testing
- Lumateperone high dose, Lumateperone low dose
- Where
- 35 sites in United States
- Volunteers
- 160 people
- Sponsor
- Intra-Cellular Therapies, Inc.
Septicemia, Bacterial Infections
Efficacy and Safety of Colistin Based Antibiotic Therapy
To evaluate the efficacy and safety of antibiotic combinations containing Colistin in the treatment of children with multidrug-resistant gram negative infections admitted in the pediatric surgery intensive care unit.
- Trial name
- NCT04764058
- Testing
- Tienam 500, Infusion
- Where
- Egypt
- Volunteers
- 60 people
- Sponsor
- Ain Shams University
Atopic Dermatitis
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
- Trial name
- NCT03961529
- Testing
- 0.3% OPA-15406 ointment, 1% OPA-15406 ointment
- Where
- Japan
- Volunteers
- 366 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Anesthesia
Comparison of Intranasal Kovacaine Mist, and Placebo for Anesthetizing Maxillary Teeth in Pediatric Patients
The purpose of this study is to compare the efficacy of Kovacaine Mist, and Placebo for inducing pulpal anesthesia of the maxillary teeth in pediatric patients.
- Trial name
- NCT01844830
- Testing
- Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
- Where
- 2 sites in United States
- Volunteers
- 90 people
- Sponsor
- St. Renatus, LLC
Iron Deficiency Anemia
A Study to Evaluate Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects
This is a Phase 3, randomized, open-label, multicenter, study in male and female pediatric subjects (2 years to <18 years of age) with IDA, or felt by their clinician to be at risk of developing IDA.
- Trial name
- NCT03893045
- Testing
- ferumoxytol, Iron sucrose
- Where
- 15 sites in United States, Lithuania and 1 more
- Volunteers
- 75 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Central Precocious Puberty
A Study to Assess the Efficacy, Safety, and Pharmacokinetics of Debio 4326 in Pediatric Participants With Central Precocious Puberty (LIBELULA™ Clinical Trial)
The primary objective of this study is to evaluate the efficacy of Debio 4326 in suppressing serum luteinizing hormone (LH) to prepubertal levels 52 weeks after the first Debio 4326 injection in pediatric participants with…
- Trial name
- NCT06129539
- Testing
- Debio 4326
- Where
- 17 sites in United States, Argentina and 3 more
- Volunteers
- 56 people
- Sponsor
- Debiopharm International SA
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