Clinical trials: Pediatric Safety and Effectiveness
Solid Tumors
Pharmacodynamics, Pharmacokinetics, Efficacy and Safety of Balugrastim in Pediatric Patients With Solid Tumors
The primary objective of this study is to find the optimal dose of balugrastim by characterizing its pharmacokinetics (PK), and by comparing the pharmacodynamics (PD) of balugrastim to filgrastim in children receiving…
- Trial name
- NCT01940601
- Testing
- Balugrastim, Filgrastim
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Lysosomal Storage Disorders, Sandhoff Disease
Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of PLX-200 in Pediatric Patients (Master Protocol)
The purpose of this study is to evaluate the safety, tolerability and clinical activity of PLX-200 in pediatric patients with lysosomal storage disorders.
- Conditions
- Lysosomal Storage Disorders, Sandhoff Disease, Krabbe Disease, CLN2
- Trial name
- NCT07740512
- Testing
- PLX-200
- Volunteers
- 24 people
- Sponsor
- Polaryx Therapeutics, Inc.
Locally Resectable Pediatrics Tumors
CEB-01 in Pediatrics With Locally Resectable Abdominal Tumors
The CEB-01 implant is a membrane containing SN-38, the active metabolite of irinotecan, an already authorized chemotherapeutic agent.
- Trial name
- NCT06986811
- Testing
- Standard surgery, CEB-01
- Where
- Spain
- Volunteers
- 80 people
- Sponsor
- CEBIOTEX
Neuroectodermal Tumors, Rhabdomyosarcoma
Trial of Afatinib in Pediatric Tumours
Open-label, dose escalation, monotherapy, basket trial with biomarker specific MTD expansion cohort/Phase II part. The trial will consist of 2 parts: 1. Dose finding part to determine the MTD 2.
- Trial name
- NCT02372006
- Testing
- afatinib
- Where
- 28 sites in United States, Australia and 10 more
- Volunteers
- 56 people
- Sponsor
- Boehringer Ingelheim
Kawasaki Disease
A Study to Evaluate the Use and Safety of CARDIOLITE® in Pediatric Patients With Kawasaki Disease
Determine the predictive value of CARDIOLITE® rest and stress myocardial perfusion imaging (MPI) to define a pediatric population with Kawasaki Disease (KD) at high and low risk of developing cardiac events.
- Trial name
- NCT00162032
- Testing
- Sestamibi
- Where
- 50 sites in United States, Brazil and 5 more
- Volunteers
- 445 people
- Sponsor
- Lantheus Medical Imaging
Obesity, Overweight
A Platform Trial for Pediatric Participants With Obesity or Overweight (LY900040)
The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric…
- Trial name
- ADVANCE (NCT06672549)
- Testing
- Orforglipron
- Where
- 117 sites in United States, Belgium and 11 more
- Volunteers
- 125 people
- Sponsor
- Eli Lilly and Company
Venous Thromboembolism
EINSTEIN Junior: Oral Rivaroxaban in Children With Venous Thrombosis
The purpose of this study is to evaluate comparative efficacy and safety of rivaroxaban to standard of care in children with acute venous thromboembolism.
- Trial name
- EINSTEIN Jr (NCT02234843)
- Testing
- Rivaroxaban (Xarelto, BAY59-7939), Standard of Care
- Where
- 109 sites in United States, Argentina and 26 more
- Volunteers
- 500 people
- Sponsor
- Bayer
Anesthesia
Dose-Finding Pediatric and Adult Trial With Sugammadex (Org 25969, MK-8616, SCH 900616) (19.4.306) (MK-8616-034) (P05961)
The purpose of this study is: to explore the dose-response relation of sugammadex (Org 25969, MK-8616, SCH 900616) given as a reversal agent at reappearance of T2 after 0.6 mg.kg-1 rocuronium in pediatric and adult participants…
- Trial name
- NCT00421148
- Testing
- Sugammadex 0.5 mg/kg, Sugammadex 1 mg/kg, Sugammadex 2 mg/kg
- Volunteers
- 94 people
- Sponsor
- Merck Sharp & Dohme LLC
Asthma
Albuterol HFA MDI in Pediatric Participants With Asthma
The primary objective of this study is to evaluate the chronic-dose and efficacy of Albuterol-HFA-MDI relative to placebo in pediatric asthmatics.
- Trial name
- NCT00577655
- Testing
- Albuterol, Proventil® HFA
- Where
- 13 sites in United States
- Volunteers
- 103 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics Study of Tolvaptan in Pediatric Congestive Heart Failure (CHF) Patients With Volume Overload
To determine the efficacy, safety, and dose and regimen of tolvaptan in pediatric CHF patients with volume overload
- Trial name
- NCT03255226
- Testing
- Tolvaptan
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Feeding and Eating Disorders of Childhood, Appetite Disorders
Biolizin for Improving Functional Poor Appetite in Children Aged 6 to 36 Months (CTBE2502)
Functional poor appetite is common in young children and may be linked to suboptimal micronutrient intake and feeding behavior. This study evaluates whether a zinc-containing oral supplement (Biolizin syrup) can improve eating…
- Conditions
- Feeding and Eating Disorders of Childhood, Appetite Disorders, Functional Poor Appetite
- Trial name
- CTBE2502 (NCT07153549)
- Testing
- Biolizin, Standardized caregiver counseling on responsive feeding
- Where
- Vietnam
- Volunteers
- 110 people
- Sponsor
- Haiphong University of Medicine and Pharmacy
Endoscopy, Insufflation
Safety and Efficacy of CO2 for Endoscopy
Hypothesis: Carbon dioxide gas use for endoscopic insufflation is safe and results in less abdominal distension and discomfort; it is equally effective as air in pediatric patients undergoing endoscopic procedures.
- Trial name
- NCT03287687
- Testing
- Carbon dioxide (CO2) gas insufflation, Air insufflation
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Warren Bishop
Obesity, Childhood
Endosleeve in Adolescents
In this study, the investigators assess the safety and efficacy of endoscopic sleeve gastroplasty in adolescents with obesity.
- Trial name
- NCT03778697
- Testing
- Endoscopic Sleeve Gastroplasty
- Where
- Saudi Arabia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- King Saud University
Osteochondrodysplasia
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAR442501 in Pediatric Participants With Achondroplasia
This is a Phase 2, open-label, multicenter, study to evaluate safety, tolerability and efficacy of SAR442501 in children from birth up to 12 years of age with Achondroplasia.
- Trial name
- upreACH-2 (NCT06067425)
- Testing
- SAR442501
- Where
- 9 sites in Australia, China and 3 more
- Volunteers
- 16 people
- Sponsor
- Sanofi
Hypophosphatemia, Hypophosphatemic Rickets
Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets
A 52 week, open label trial to assess the safety and efficacy of KRN23, an investigational antibody to FGF23, in a single pediatric patient with Epidermal Nevus Syndrome(ENS) and associated hypophosphatemic rickets A 26 weeks…
- Conditions
- Hypophosphatemia, Hypophosphatemic Rickets, Pain, Chronic
- Trial name
- NCT03581591
- Testing
- Burosumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Redwood Dermatology Sciences
Growth Hormone Deficiency, Endocrine System Diseases
Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency
This study is conducted in China only. The purpose is to demonstrate the efficacy and safety of once weekly dosing of TransCon hGH, a long-acting growth hormone product, compare to once-daily dosing of human growth hormone (hGH)…
- Conditions
- Growth Hormone Deficiency, Endocrine System Diseases, Hormones, Pituitary Diseases
- Trial name
- NCT04326374
- Testing
- TransCon hGH, daily hGH
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Visen Pharmaceuticals (Shanghai) Co., Ltd.
Gastroesophageal Reflux
Safety and Efficacy of Rabeprazole in Infants With Gastroesophageal Erosive Reflux Disease (GERD)
The purpose of this study is to assess the effectiveness and safety of rabeprazole sodium, an inhibitor of gastric acid secretion of the protein pump inhibitor (PPI) class, compared with placebo in the treatment of…
- Trial name
- NCT00992589
- Testing
- Rabeprazole sodium 5 mg, Rabeprazole sodium 10 mg
- Where
- 81 sites in United States, Australia and 8 more
- Volunteers
- 344 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
HIV Infections
The Safety and Effectiveness of Zidovudine Plus Lamivudine, Used With and Without 1592U89, in HIV-1 Infected Children Who Have Taken Anti-HIV-1 Drugs
To compare the safety, tolerance, durability of the viral load response and the antiviral activity of the 1592U89/zidovudine(ZDV)/lamivudine (3TC) regimen vs. ZDV/3TC regimen.
- Trial name
- NCT00002391
- Testing
- Abacavir sulfate, Lamivudine, Zidovudine
- Where
- 30 sites in United States
- Sponsor
- Glaxo Wellcome
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.
Burns
Efficacy and Safety Study of Caldolor (Intravenous Ibuprofen) in Hospitalized Adult and Pediatric Burn Patients
The primary objective of this study of Caldolor administered to hospitalized adult and pediatric burn patients is to determine the efficacy of Caldolor on reducing fever when compared to placebo when administered every 6 hours…
- Trial name
- NCT00606489
- Testing
- Caldolor
- Where
- 5 sites in United States, India
- Volunteers
- 61 people
- Sponsor
- Cumberland Pharmaceuticals
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