Clinical trials: Pediatric Safety and Effectiveness
Congenital Heart Disease in Children
BAX602 in Preventing the Adhesion Around Great Cardiac Vessels in Pediatric Patients With Congenital Heart Disease Undergoing Re-do Open Heart Surgery (Japan Trial)
Congenital heart disease occurs in about 1% of live births and can range from (1) naturally curable conditions that require no treatment to (2) conditions that require multiple immediate operations or refractory severe…
- Trial name
- NCT05647161
- Testing
- BAX602, No Intervention
- Where
- 6 sites in Japan
- Volunteers
- 34 people
- Sponsor
- Baxter Healthcare Corporation
Steroid Refractory GVHD
Evaluation of EFficacy and SaFEty of Leukotac (Inolimomab) in Pediatric Patients With SR-aGvHD
A Phase 3, Multicenter, open label, study to Evaluate the EFficacy and SaFEty of Leukotac® (inolimomab) in pediatric patients with steroid resistant acute Graft versus Host Disease (SR-aGvHD)
- Trial name
- EiFFEL (NCT04289103)
- Testing
- Inolimomab (Leukotac)
- Volunteers
- 65 people
- Sponsor
- ElsaLys Biotech
Anemia
Study of the Safety and Efficacy of Ferrlecit® Maintenance Dosing in Pediatric Hemodialysis Patients
A phase 4 clinical investigation in iron-replete pediatric hemodialysis patients, whose legal guardian had provided signed informed consent, and who had satisfied the inclusion and exclusion criteria of the study.
- Trial name
- NCT00224003
- Testing
- Sodium Ferric Gluconate Complex in Sucrose.
- Where
- 10 sites in United States
- Volunteers
- 23 people
- Sponsor
- Watson Pharmaceuticals
Muscular Dystrophies, Limb-Girdle
A Study of SRP-9005 in Limb Girdle Muscular Dystrophy Type 2C/R5 Pediatric and Adult Participants
This is a study of a single systemic dose of SRP-9005 in pediatric and adult participants with limb girdle muscular dystrophy type 2C/R5 (LGMD2C/R5).
- Trial name
- COMPASS (NCT06952686)
- Testing
- SRP-9005, Corticosteroid
- Where
- United States
- Sponsor
- Sarepta Therapeutics, Inc.
Autism
Lurasidone Pediatric Autism Study
This is a randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of 2 fixed doses of lurasidone (20 mg/day and 60 mg/day) for 6 weeks compared with placebo in pediatric and adolescent…
- Trial name
- NCT01911442
- Testing
- Lurasidone 20 mg daily, Lurasidone
- Where
- 41 sites in United States
- Volunteers
- 150 people
- Sponsor
- Sumitomo Pharma America, Inc.
Chemotherapy Induced Nausea and Vomiting Pediatric Cancer Patients
Efficacy and Safety of Fosaprepitant in Preventing Chemotherapy-induced Vomiting in Children Treated With Medium and High Emetic Chemotherapeutic Drugs
This study was a prospective, randomized, double-blind, parallel controlled clinical trial. The children who met the inclusion criteria and were treated with medium and high emetic chemotherapy drugs were randomly included in the…
- Trial name
- NCT05230654
- Testing
- Fosaprepitant
- Where
- China
- Volunteers
- 120 people
- Sponsor
- Shanghai Children's Medical Center
Bipolar Depression
Pediatric Bipolar Depression
The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with…
- Trial name
- NCT00811473
- Testing
- Quetiapine XR
- Where
- 48 sites in United States, Colombia and 5 more
- Volunteers
- 193 people
- Sponsor
- AstraZeneca
Skin Diseases, Infection
Study Evaluating Tigecycline Versus Clindamycin Or Vancomycin On Complicated Skin And Skin Structure Infections Including Those Due To Methicillin-Resistant Staphylococcus Aureus (MRSA) In Pediatric Subjects
The main purpose of this study is to compare the safety and efficacy of tigecycline versus clindamycin (including subjects treated with vancomycin) in pediatric subjects (aged 8 to 17 years) with complicated skin and skin…
- Trial name
- NCT00911573
- Testing
- Tigecycline, Clindamycin (or Vancomycin if needed)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Inflammatory Bowel Diseases, Crohn Disease
Conventional vs Biologic Therapy in Pediatric IBD
This combined retrospective-prospective cohort study aims to evaluate the effectiveness, safety, and adverse events of conventional versus biologic therapy in children and adolescents with inflammatory bowel disease at Assiut…
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- Trial name
- NCT07818473
- Volunteers
- 100 people
- Sponsor
- Assiut University
Hypertension
Study of Losartan in Pediatric Patients With Hypertension (MK-0954-337)
This study will explore the dose-response of losartan as well as the safety and tolerability in children from 6 months to 6 years of age.
- Trial name
- NCT00756938
- Testing
- losartan potassium
- Volunteers
- 101 people
- Sponsor
- Organon and Co
Atelectasis, Postoperative Complications
Ultrasound-guided Lung Recruitment Maneuvers for Postoperative Pediatric Atelectasis
In anesthetized children, the incidence of lung collapse with episodes of hypoxemia is high. Diaphragmatic dysfunction induced by general anesthesia is one of the most important factors in the genesis of regional losses of lung…
- Conditions
- Atelectasis, Postoperative Complications, Recruitment, Pediatric
- Trial name
- NCT05777018
- Testing
- conventional recruitment maneuvers, ultrasound-guided recruitment maneuvers
- Where
- Egypt
- Volunteers
- 90 people
- Sponsor
- Tanta University
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
Iron Overload
Safety and Efficacy of Ferriprox™ (Deferiprone) Oral Solution in Iron Overloaded Pediatric Patients
The primary objective is to assess the safety of Ferriprox oral solution for the treatment of iron overload in pediatric patients with transfusion-dependent anemia.
- Trial name
- NCT00529152
- Testing
- Deferiprone
- Where
- 4 sites in Egypt, Indonesia and 1 more
- Volunteers
- 100 people
- Sponsor
- ApoPharma
Pediatric Ulcerative Colitis
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650…
- Trial name
- NCT01585155
- Testing
- TA-650
- Where
- 7 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Tanabe Pharma Corporation
Hodgkin Lymphoma, Lymphocytic Leukemia
Pilot Study of Non-Myeloablative, HLA-Matched Allogeneic Stem Cell Transplantation for Pediatric Hematopoietic Malignancies
Background: Allogeneic blood and marrow stem cell transplantation (BMT) plays an important role in the curative treatment of a number of pediatric malignancies.
- Conditions
- Hodgkin Lymphoma, Lymphocytic Leukemia, Mixed Cell Leukemia, Myelodysplastic Syndrome
- Trial name
- NCT00013533
- Testing
- Stem cell transplantation
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Cancer Institute (NCI)
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
Type 1 Diabetes Mellitus
Real-world Study on the Effectiveness and Safety of Control-IQ Technology in Teenagers With Type 1 Diabetes Engaging in Regular Physical Activity
We hypothesize that the use of the Control-IQ system positively influences glycemic control in teenagers with type 1 diabetes during physical activity.
- Trial name
- PED-CIQAcT1ve (NCT06876207)
- Testing
- Tandem t:slim X2 with Control-IQ technology
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- Bruno Bombaci
Thymidine Kinase 2 Deficiency
A Study of the Efficacy and Safety of MT1621 in Thymidine Kinase 2 (TK2) Deficiency (Treatment naïve)
This is a Phase 3b, prospective, single-arm, multicenter, open-label treatment study of the efficacy and safety of MT1621 in pediatric and adolescent patients with thymidine kinase 2 deficiency (TK2d).
- Trial name
- NCT04581733
- Testing
- MT1621
- Sponsor
- Zogenix MDS, Inc.
Chronic Iron Overload
Extended Evaluation of Deferasirox Film-coated Tablet (FCT) Formulation
Extend evaluation of deferasirox film-coated tablet (FCT) formulation
- Trial name
- NCT02720536
- Testing
- Deferasirox
- Where
- 14 sites in Austria, Greece and 1 more
- Volunteers
- 53 people
- Sponsor
- Novartis Pharmaceuticals
Ventricular Septal Defect, Atrioventricular Septal Defect
A Study Evaluating the Efficacy and Safety of IV L-Citrulline for the Prevention of Clinical Sequelae of Acute Lung Injury Induced by Cardiopulmonary Bypass in Pediatric Patients Undergoing Surgery for Congenital Heart Defects
This is a randomized, double-blind, placebo controlled, multicenter study to compare the efficacy and safety of L-citrulline versus placebo in patients undergoing surgery for congenital heart defects.
- Conditions
- Ventricular Septal Defect, Atrioventricular Septal Defect, Primum Atrial Septal Defect
- Trial name
- NCT05253209
- Testing
- L-citrulline, Plasmalyte A
- Where
- 10 sites in United States
- Volunteers
- 64 people
- Sponsor
- Asklepion Pharmaceuticals, LLC
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