Clinical trials: Pediatric Safety and Effectiveness
Iron Deficiency Anemia
A Trial of Ferumoxytol for the Episodic Treatment of Iron Deficiency Anemia in Pediatric Participants With Chronic Kidney Disease
Study AMAG-FER-CKD-253 is an extension study of the combined AMAG-FER-CKD-251 (NCT01155375) and AMAG-FER-CKD-252 (NCT01155388) studies to evaluate the efficacy and safety of episodic treatment of iron deficiency anemia (IDA) with…
- Trial name
- NCT01264679
- Testing
- Ferumoxytol
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- AMAG Pharmaceuticals, Inc.
Nephropathic Cystinosis
DFT383 in Pediatric Participants With Nephropathic Cystinosis
An open-label, multi-center, phase I/II study to assess the safety, tolerability and efficacy of DFT383 in pediatric participants with nephropathic cystinosis, followed by a long-term extension phase.
- Trial name
- CYStem (NCT06910813)
- Testing
- DFT383
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
AML, Childhood, Relapse/Recurrence
Safety and Efficacy of Avapritinib in Relapsed or Refractory Pediatric CBF-AML With KIT Mutation
The purpose of this study is to evaluate the efficacy and safety of avapritinib in relapsed or refractory pediatric core binding factor acute myeloid leukemia with KIT mutation.
- Conditions
- AML, Childhood, Relapse/Recurrence, Refractory AML, Core Binding Factor Acute Myeloid Leukemia
- Trial name
- NCT06316960
- Testing
- Avapritinib, Azacitidine Injection, Decitabine Injection
- Where
- 12 sites in China
- Volunteers
- 50 people
- Sponsor
- Children's Hospital of Soochow University
B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma
Substudy 01A: Zilovertamab Vedotin in Pediatric and Young Adult Participants With Hematologic Malignancies or Solid Tumors (MK-9999-01A/LIGHTBEAM-U01)
Substudy 01A is part of a platform study. The purpose of this study is to assess the efficacy and safety of zilovertamab vedotin in pediatric participants with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL)…
- Conditions
- B-cell Acute Lymphoblastic Leukemia, Diffuse Large B-cell Lymphoma, Burkitt Lymphoma, Neuroblastoma
- Trial name
- NCT06395103
- Testing
- Zilovertamab vedotin
- Where
- 71 sites in United States, Australia and 21 more
- Volunteers
- 90 people
- Sponsor
- Merck Sharp & Dohme LLC
Major Depressive Disorder
Phase IV:Safety and Efficacy of EMSAM in Adolescents With Major Depression
The primary purpose of your participation in this study is to help answer the following research question: Whether 12-week administration of EMSAM (selegiline transdermal system) is safe and effective for the treatment of…
- Trial name
- NCT00531947
- Testing
- Selegiline Transdermal System
- Where
- 20 sites in United States
- Volunteers
- 308 people
- Sponsor
- Somerset Pharmaceuticals
Haemophilia A
BAY81-8973 Pediatric Safety and Efficacy Trial
The primary objective was to evaluate the safety and efficacy of the treatment with BAY81-8973 for prophylaxis and treatment of breakthrough bleeds in children with severe hemophilia A.
- Trial name
- NCT01311648
- Testing
- Recombinant Factor VIII (Kovaltry, BAY81-8973)
- Where
- 43 sites in United States, Argentina and 15 more
- Volunteers
- 94 people
- Sponsor
- Bayer
Pediatric Renal Stones
Efficacy and Safety of Flexible Ureteroscopy With Flexible Navigable Suction Ureteral Access Sheath Versus Mini-Percutaneous Nephrolithotomy With Vacuum-Assisted Access Sheath
Mini-percutaneous nephrolithotomy (mini-PCNL) and retrograde intrarenal surgery (RIRS) are both effective treatment modalities for renal calculi measuring up to 2.5 cm in pediatric patients, demonstrating similar efficacy and…
- Trial name
- NCT07763743
- Testing
- Flexible Ureteroscopy
- Where
- Egypt
- Volunteers
- 72 people
- Sponsor
- Ain Shams University
Thrombosis
Pharmacokinetic, Pharmacodynamic, Safety, and Efficacy Study of Rivaroxaban for Thromboprophylaxis in Pediatric Participants 2 to 8 Years of Age After the Fontan Procedure
The Purpose of this study is to characterize the single and multiple-dose pharmacokinetic (PK) and pharmacokinetic/pharmacodynamic (PK/ PD) profiles after oral rivaroxaban therapy administered to pediatric participants 2 to 8…
- Trial name
- UNIVERSE (NCT02846532)
- Testing
- Rivaroxaban, Acetylsalicylic Acid
- Where
- 42 sites in United States, Argentina and 8 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Severe Hemophilia A
Study of Efficacy and Safety of FRSW107 in Pediatric Patients With Severe Hemophilia A
This study was divided into four stages: screening period, main trial period, extension period and follow-up period. In the main trial, both groups received FRSW107 prophylactic therapy.
- Trial name
- NCT06136507
- Testing
- FRSW107
- Where
- 13 sites in China
- Volunteers
- 76 people
- Sponsor
- Hangzhou Gensciences Biopharmaceutical Co., Ltd.
Adverse Drug Reactions
Influence of CYP2C19 Genotype on Safety and Efficacy of Voriconazole in Pediatric Patients With Hematologic Malignancy
Voriconazole is a drug used to treat invasive fungal infections. The amount of voriconazole in a person's blood helps to determine how effectively it treats an infection, and how safe it is.
- Trial name
- NCT04743544
- Testing
- Voriconazole
- Where
- Turkey (Türkiye)
- Volunteers
- 62 people
- Sponsor
- Dokuz Eylul University
Infections, Pediatrics
Safety and Efficacy Study of Ceftaroline Versus a Comparator in Pediatric Subjects With Complicated Skin Infections
This is a study of safety, effectiveness, blood levels and tolerance of Ceftaroline fosamil in children with skin infections receiving antibiotic therapy in the hospital.
- Trial name
- NCT01400867
- Testing
- Ceftaroline fosamil, Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam, Cephalexin or Clindamycin or Linezolid
- Where
- 71 sites in United States, Argentina and 8 more
- Volunteers
- 163 people
- Sponsor
- Forest Laboratories
Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children
Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery
This is a prospective, multi-center, single-arm, target-value clinical trial conducted to evaluate the safety and effectiveness of the Thoracic and Abdominal Endoscopic Surgery System (model WJ-SR01-200) in pediatric surgical…
- Conditions
- Indications for Laparoscopic Thoracic and Abdominal Surgery in Children, Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children, Pyeloplasty, Ureteral Reimplantation
- Trial name
- NCT07530133
- Testing
- Thoracic and Abdominal Endoscopic Surgery System
- Where
- 3 sites in China
- Volunteers
- 64 people
- Sponsor
- Hangzhou Kangji Weijing Medical Robotics Co., Ltd.
Pediatric Subjects With Diabetes Mellitus
Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus
The primary objective of the study is to evaluate the safety and effectiveness of the G4 System (System) when used as an adjuvant to blood glucose testing over a 7-day period in pediatric subjects with diabetes mellitus.
- Trial name
- NCT01667185
- Where
- 6 sites in United States
- Volunteers
- 176 people
- Sponsor
- DexCom, Inc.
Von Willebrand Disease
Efficacy and Safety of Fanhdi®, a High-purity Von Willebrand Containing FVIII Concentrate, in Pediatric Patients With Von Willebrand Disease
Multicenter, prospective, non-controlled study in a pediatric cohort (<6 years-old) with severe (type 2 or 3) hereditary Von Willebrand Disease (VWD).
- Trial name
- NCT02472665
- Testing
- plasma-derived FVIII/VWF concentrate
- Where
- 4 sites in Spain
- Sponsor
- Grifols Therapeutics LLC
Congenital Heart Diseases
Ulinastatin Injection in in Pediatric Patients Undergoing Open Heart Surgery
1. Explore the efficacy of Ulinastatin use in improving post-operative pulmonary insufficiency and safety in pediatric patients undergoing scheduled CPB open heart surgery to treat Complex Congenital Heart Disease 2.
- Trial name
- NCT02527811
- Testing
- Ulinastatin
- Where
- 5 sites in China
- Volunteers
- 450 people
- Sponsor
- Techpool Bio-Pharma Co., Ltd.
Skin; Deformity
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years
To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only).
- Trial name
- NCT03624192
- Testing
- RECELL® Autologous Cell Harvesting Device, Telfa™ Clear and Xeroform™ dressings
- Where
- 7 sites in United States
- Volunteers
- 3 people
- Sponsor
- Avita Medical
Urea Cycle Disorder
A Safety and Efficacy Study of Infusions of HepaStem in Urea Cycle Disorders Pediatric Patients
This is a phase2, prospective, open label study designed to investigate the safety and efficacy of several infusions of HepaStem. This study will include 5 pediatric Urea Cycle Disorder (UCD) patients under 12 years old.
- Trial name
- NCT03884959
- Testing
- HepaStem Infusion
- Where
- South Korea
- Sponsor
- HLB Cell Co., Ltd.
Neuroblastoma, CNS Metastases
131I-omburtamab Radioimmunotherapy for Neuroblastoma Central Nervous System/Leptomeningeal Metastases
Children with a neuroblastoma diagnose and central nervous system (CNS)/leptomeningeal metastases will be given up to 2 rounds of intracerebroventricular treatment with a radiolabelled monoclonal antibody, 131I-omburtamab to…
- Conditions
- Neuroblastoma, CNS Metastases, Leptomeningeal Metastases
- Trial name
- NCT03275402
- Testing
- 131I-omburtamab
- Where
- 8 sites in United States, Denmark and 2 more
- Volunteers
- 52 people
- Sponsor
- Y-mAbs Therapeutics
COVID-19
Safety, Tolerability, and Efficacy of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies for the Treatment of Ambulatory Adult and Pediatric Patients With COVID-19
Phase 1 To evaluate the safety and tolerability of REGN10933+REGN10987 compared to placebo To evaluate the virologic efficacy of REGN10933+REGN10987 compared to placebo in reducing viral load of SARS-CoV-2 Phase 2 To evaluate the…
- Trial name
- NCT04425629
- Testing
- casirivimab+imdevimab combination therapy
- Where
- 114 sites in United States, Mexico and 1 more
- Volunteers
- 10,078 people
- Sponsor
- Regeneron Pharmaceuticals
Cough
Efficacy, Safety and Palatability of the Syrup "KalobaTuss® Children" for the Treatment of Cough in Children
Cough of children is one of the most frequent events for which parents ask for a medical consult and it is a true challenge for pediatrics during daily practice.
- Trial name
- KALOCOUGH (NCT04073251)
- Testing
- KalobaTuss children
- Where
- Italy
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
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