Clinical trials: Pediatric Safety and Effectiveness
Thromboembolism
Rivaroxaban for Treatment in Venous or Arterial Thrombosis in Neonates
The purpose of this study is to find out whether rivaroxaban is safe and effective to use in children age newborn to less than 6 months and how long it stays in the body and how it is used in the body.
- Trial name
- Einstein Jr (NCT02564718)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939)
- Where
- 9 sites in Austria, France and 5 more
- Volunteers
- 10 people
- Sponsor
- Bayer
Immune Thrombocytopenia, Treatment
Avatrombopag in the Treatment of Pediatric Immune Thrombocytopenia
To evaluate the safety and efficacy of avatrombopag in the treatment of pediatric primary immune thrombocytopenia in patients who have been treated with eltrombopag before and switched to avatrobopag because of poor efficacy…
- Trial name
- NCT06281327
- Testing
- Avatrombopag
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Institute of Hematology & Blood Diseases Hospital, China
Lennox Gastaut Syndrome (LGS)
A Study of Soticlestat as an Add-on Therapy in Children, Teenagers, and Adults With Lennox-Gastaut Syndrome
The aims of the study are: to learn if soticlestat, when given as add-on therapy, reduces the number of major motor drop seizures in children, teenagers, and adults with Lennox-Gastaut Syndrome.
- Trial name
- NCT04938427
- Testing
- Soticlestat
- Where
- 98 sites in United States, Australia and 16 more
- Volunteers
- 270 people
- Sponsor
- Takeda
Tourette Syndrome
Safety and Efficacy Study of NBI-98854 in Children and Adolescents With Tourette Syndrome
Phase 2, double-blind, placebo-controlled study to assess the safety and efficacy of NBI-98854 administered once daily (qd) for a total of 6 weeks of treatment.
- Trial name
- NCT02679079
- Testing
- NBI-98854
- Where
- 44 sites in United States
- Volunteers
- 98 people
- Sponsor
- Neurocrine Biosciences
Sedation
Study Evaluating Safety and Efficacy of Dexmedetomidine (DEX) in Intubated and Mechanically Ventilated Pediatric Intensive Care Unit (PICU) Subjects
The purpose of this study is to evaluate the safety and efficacy of dexmedetomidine (DEX) in intubated and mechanically ventilated pediatric intensive care unit (PICU) subjects.
- Trial name
- NCT00875550
- Testing
- Dexmedetomidine, Midazolam, Fentanyl
- Where
- 37 sites in United States, Canada
- Volunteers
- 175 people
- Sponsor
- Hospira, now a wholly owned subsidiary of Pfizer
Primary Immunoglobulin A Nephropathy (IgAN)
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Iptacopan in Pediatric Patients With Primary IgAN
The study is an open-label, single arm, multicenter, Phase III study to determine proteinuria reduction, pharmacokinetics (PK), safety and tolerability (including CV surveillance) of iptacopan in primary immunoglobulin A…
- Trial name
- NCT06994845
- Testing
- iptacopan
- Where
- 20 sites in United States, Argentina and 6 more
- Volunteers
- 31 people
- Sponsor
- Novartis Pharmaceuticals
Gastroesophageal Reflux Disease (GERD)
A Study to Check the Safety of Dexlansoprazole and Learn if it Can Treat Symptomatic Nonerosive Gastroesophageal Reflux Disease in Children 2 to 11 Years Old
Gastroesophageal reflux disease (GERD) is caused by food or acid coming up from the stomach into the esophagus, repeatedly. The esophagus is the tube that carries food and liquids from the mouth to the stomach.
- Trial name
- NCT02616302
- Testing
- Dexlansoprazole
- Where
- 18 sites in United States, Canada and 3 more
- Volunteers
- 71 people
- Sponsor
- Takeda
Short Bowel Syndrome
A Study of Teduglutide (Revestive®) in Children, Teenagers and Adults With Short Bowel Disease
The main aims of the study are to assess the safety profile of Teduglutide (Revestive®) in people with Short Bowel Disease as well as how well people respond to the treatment with Teduglutide (Revestive®).
- Trial name
- NCT04877431
- Where
- Argentina
- Volunteers
- 45 people
- Sponsor
- Takeda
Newly Diagnosed Pediatric ITP
Safety, Tolerability and Efficacy of Single Dose Low Cost Minipool Intravenous Immunoglobulins in Moderately Severe Newly Diagnosed ITP
To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.
- Trial name
- NCT02669277
- Testing
- IVIG prepared by minipool technology, standard IVIG product
- Where
- Egypt
- Volunteers
- 72 people
- Sponsor
- Ain Shams University
Sepsis
Efficacy of Betalactam Antibiotics in Prolonged Infusion Compared to Intermittent in Pediatric Patients With Sepsis
This study evaluates the efficacy and safety of the administration of betalactam antibiotics in prolonged infusion compared to intermittent infusion in children with sepsis.
- Trial name
- NCT03019965
- Testing
- Intermittent Piperacillin/tazobactam, Continuous Piperacillin/tazobactam, Intermittent Imipenem
- Where
- 2 sites in Mexico
- Volunteers
- 426 people
- Sponsor
- Coordinación de Investigación en Salud, Mexico
Pediatric Psoriasis
Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis
Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of Pediatric Psoriasis was approved on 23 Sep 2009.
- Trial name
- NCT01432249
- Testing
- Enbrel group
- Sponsor
- Pfizer
Chronic Kidney Disease; Iron Deficiency Anemia
A Study to Evaluate the Safety (Compared to Iron Sucrose), Efficacy and Pharmacokinetics of Ferumoxytol for the Treatment of Iron Deficiency Anemia (IDA) in Pediatric Subjects With Chronic Kidney Disease (CKD)
Primary Objectives: To evaluate the safety (compared to iron sucrose) and efficacy of ferumoxytol in pediatric CKD subjects with iron deficiency anemia (IDA) or who are at risk of development of IDA Secondary Objective: To…
- Trial name
- NCT03619850
- Testing
- Ferumoxytol, Iron sucrose
- Where
- 21 sites in United States, Hungary and 3 more
- Volunteers
- 129 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Pupillary Dilation Effect During Cycloplegic Refraction
Comparing Efficacy and Safety of CTO0303 in Pediatric Subjects
This is a prospective randomized study compared with active control arm.
- Trial name
- NCT06609525
- Testing
- CTO0303-A, CTO0303-B, CTO0303-C
- Where
- South Korea
- Volunteers
- 156 people, healthy volunteers welcome
- Sponsor
- Taejoon Pharmaceutical Co., Ltd.
Overactive Detrusor, Neurogenic Bladder
Safety and Efficacy Evaluation of Oxybutynin Topical Gel In Children With Neurogenic Bladder
This study will evaluate the safety and efficacy of Oxybutynin Chloride 10% Topical Gel in children 3 to less than 17 years old, who have overactive bladder due to a neurogenic condition.
- Trial name
- NCT01192568
- Testing
- Oxybutynin
- Where
- 10 sites in United States
- Volunteers
- 52 people
- Sponsor
- AbbVie
Cataract
Loteprednol vs Prednisolone for the Treatment of Intraocular Inflammation Following Cataract Surgery in Children.
The objective of this study is to compare the efficacy and safety for the treatment of postoperative inflammation following ocular surgery for childhood cataract.
- Trial name
- NCT01475643
- Testing
- Loteprednol etabonate, Prednisolones acetate
- Where
- United States
- Volunteers
- 107 people
- Sponsor
- Bausch & Lomb Incorporated
Neutropenia, Hematopoietic Stem Cell Transplantation
Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation
This study is to evaluate safety and prophylaxis effect of micafungin after hematopoietic stem cell transplantation. Micafungin is administered until confirmation of neutrophil engraftment or treatment failure.
- Conditions
- Neutropenia, Hematopoietic Stem Cell Transplantation, Invasive Fungal Disease
- Trial name
- NCT01135589
- Testing
- Micafungin
- Where
- 7 sites in South Korea
- Volunteers
- 145 people
- Sponsor
- Asan Medical Center
Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure
Inhaled Iloprost as an Adjunct to Inhaled Nitric Oxide in Pediatric Critical Care Patients
The purpose of this study is to determine whether inhaled iloprost is safe and effective in pediatric patients with pulmonary hypertension who are sick in the intensive care unit.
- Conditions
- Pulmonary Hypertension, Neonatal Hypoxic Respiratory Failure, Persistent Pulmonary Hypertension of Newborn, Congenital Heart Defects
- Trial name
- NCT00981591
- Testing
- Iloprost
- Sponsor
- Seattle Children's Hospital
HIV Infections
Trial to Evaluate Steady State Pharmacokinetic Parameters, Efficacy and Safety of Nevirapine in Antiretroviral Drug naïve Pediatric Patients
Trial to evaluate steady state pharmacokinetic parameters of nevirapine 150mg/m2 and nevirapine 4 or 7 mg/kg after 4 weeks, and efficacy and safety of the dosing when administered for 48 weeks in antiretroviral drug naïve…
- Trial name
- NCT00273975
- Testing
- Nevirapine, Lamivudine, Zidovudine
- Where
- 4 sites in South Africa
- Volunteers
- 123 people
- Sponsor
- Boehringer Ingelheim
Ulcerative Colitis
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Budesonide Extended-release Tablets in Pediatric Subjects Aged 5 to 17 Years With Active, Mild to Moderate Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, multicenter, study to evaluate the efficacy, safety, and pharmacokinetics (PK) of budesonide extended-release tablets for the induction of remission in pediatric subjects…
- Trial name
- NCT04314375
- Testing
- Low Dose Budesonide, High Dose Budesonide
- Where
- 4 sites in United States
- Volunteers
- 70 people
- Sponsor
- Bausch Health Americas, Inc.
Pediatric Cancer, Li-Fraumeni Syndrome
Arsenic Trioxide Combined With Chemotherapy for the Treatment of p53-mutated Pediatric Cancer
This prospective, single-arm, multi-center clinical trial aims to explore and evaluate the efficacy and safety of arsenic trioxide combined with chemotherapy for pediatric cancer with p53 mutation.
- Conditions
- Pediatric Cancer, Li-Fraumeni Syndrome, p53 Mutations
- Trial name
- NCT06088030
- Testing
- Arsenic trioxide
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Yang Li
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