Clinical trials: Pediatric Safety and Effectiveness
Influenza
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms
This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to <12 years of age) with…
- Trial name
- NCT03629184
- Testing
- Baloxavir Marboxil, Oseltamivir
- Where
- 37 sites in United States, Costa Rica and 5 more
- Volunteers
- 173 people
- Sponsor
- Hoffmann-La Roche
Autosomal Dominant Hypocalcemia Type 1 (ADH1)
Pharmacokinetics, Efficacy, and Safety of Encaleret in Pediatric Participants With Autosomal Dominant Hypocalcemia Type 1 (ADH1)
The overall objective of this study is to evaluate the pharmacokinetics (PK), efficacy, and safety of encaleret in pediatric participants from birth to 17 years of age with ADH1.
- Trial name
- CALIBRATE-PEDS (NCT07080385)
- Testing
- Encaleret
- Where
- 6 sites in United States, United Kingdom
- Volunteers
- 28 people
- Sponsor
- Calcilytix Therapeutics, Inc., a BridgeBio company
AADC Deficiency
A Single-Stage, Adaptive, Open-label, Dose Escalation Safety and Efficacy Study of AADC Deficiency in Pediatric Patients
The overall objective of this study is to determine the safety and efficacy of AAV2-hAADC delivered to the substantia nigra pars compacta (SNc) and ventral tegmental area (VTA) in children with aromatic L-amino acid decarboxylase…
- Trial name
- AADC (NCT02852213)
- Testing
- AAV2-hAADC
- Where
- 3 sites in United States
- Volunteers
- 42 people
- Sponsor
- Krzysztof Bankiewicz
Heart Failure, Cardiogenic Shock
Multicenter Trial of ECMO in Children With Severe Cardiac Failure Using the Cardiohelp System
There are two primary goals of this multicenter clinical trial that combines an FDA device trial and a phase II drug trial in the same study cohort. These two goals are to: 1.
- Conditions
- Heart Failure, Cardiogenic Shock, Congenital Heart Disease, Cardiomyopathies
- Trial name
- TROLLEY (NCT06080074)
- Testing
- Cardiohelp device (VA-ECMO), Heparin, Bivalirudin
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Stanford University
Neonatal Dacryocystitis, Congenital Nasolacrimal Duct Obstruction
Efficacy and Safety of Piclosept in the Complex Treatment of Neonatal Dacryocystitis
This single-center, prospective, randomized, controlled, assessor-blinded study will evaluate the efficacy and safety of Piclosept® ophthalmic solution as an adjunct to standardized lacrimal sac massage in children aged 1 to 12…
- Trial name
- NCT07875517
- Testing
- Picloxidine, Levofloxacin, Standardized lacrimal sac massage
- Where
- Kazakhstan
- Volunteers
- 90 people
- Sponsor
- Kazakh Eye Research Institute
Plaque Psoriasis
A Study to Assess the Efficacy and Safety of Apremilast in Japanese Pediatric Participants With Moderate to Severe Plaque Psoriasis
The primary objective of this study is to evaluate the efficacy of apremilast in children and adolescents (ages 6 through 17 years) with moderate to severe plaque psoriasis.
- Trial name
- NCT05565560
- Testing
- Apremilast
- Where
- 29 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Amgen
Cancer Harboring BRAF Alterations, HGG
A Study to Assess the Efficacy and Safety of FORE8394 in Participants With Cancer Harboring BRAF Alterations
The objective of this Master Protocol is to evaluate the efficacy and safety of plixorafenib in participants with BRAF altered (BRAF V600E or BRAF fusions) locally advanced or metastatic solid tumors, or recurrent or progressive…
- Conditions
- Cancer Harboring BRAF Alterations, HGG, LGG, Solid Tumors
- Trial name
- NCT05503797
- Testing
- Plixorafenib
- Where
- 70 sites in United States, Australia and 10 more
- Volunteers
- 254 people
- Sponsor
- Fore Biotherapeutics
Malnutrition, Child
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
Evaluate the safety and efficacy of Smoflipid compared to standard of care lipid emulsion Intralipid 20% administered via a central vein in pediatric patients 3 months to 16 years of age who require parenteral nutrition for at…
- Trial name
- NCT03563222
- Testing
- Smoflipid, Intralipid, 20%
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Fresenius Kabi
Hirschsprung Disease
Minimally Invasive Surgical Intervention for Hirschsprung's Disease in Pediatric Patients
Hirschsprung's disease (HD) is a congenital disorder characterized by the absence of enteric ganglion cells in the distal bowel, leading to functional obstruction, delayed meconium passage in neonates, and chronic defecation…
- Trial name
- NCT06874686
- Testing
- Minimally invasive laparoscopic pull-through surgery
- Where
- Vietnam
- Volunteers
- 1,050 people
- Sponsor
- National Children's Hospital, Vietnam
Moderate-to-severe Chronic Plaque Psoriasis
A Study of Tildrakizumab in Pediatric Subjects With Chronic Plaque Psoriasis
The study has been designed with three components. Part A is an open label PK study followed by a randomized trial component (Part B) followed by open label Long Term Extension (LTE).
- Trial name
- NCT03997786
- Testing
- Tildrakizumab, Etanercept
- Where
- 27 sites in United States, Hungary and 4 more
- Volunteers
- 135 people
- Sponsor
- Sun Pharmaceutical Industries Limited
Duchenne Muscular Dystrophy
A Long-term Follow-up Study of Participants Who Received Delandistrogene Moxeparvovec (SRP-9001) in a Previous Clinical Study
The purpose of this study is to provide a single clinical study with a uniform approach to monitoring long-term safety and efficacy in participants who received delandistrogene moxeparvovec in a previous clinical study.
- Trial name
- EXPEDITION (NCT05967351)
- Testing
- delandistrogene moxeparvovec
- Where
- 38 sites in United States, Belgium and 7 more
- Volunteers
- 400 people
- Sponsor
- Sarepta Therapeutics, Inc.
Obesity
Efficacy, Safety, and Pharmacokinetics of Tirzepatide (LY3298176) Once Weekly Versus Placebo in Pediatric Participants 6 to Less Than 12 Years of Age Who Have Obesity (ADVANCE-SURMOUNT-KIDS)
The main purpose of this study, performed under Master Protocol J4M-MC-PWMP (NCT06672549), is to evaluate the efficacy, safety, and pharmacokinetics of tirzepatide as an addition to healthy lifestyle in participants 6 to less…
- Trial name
- NCT07817875
- Testing
- Tirzepatide
- Where
- 82 sites in United States, Belgium and 8 more
- Volunteers
- 150 people
- Sponsor
- Eli Lilly and Company
Cystic Fibrosis
Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients
The purpose of this study is to determine the effect of 24 weeks of treatment with BIIL 284 BS compared with placebo on pulmonary function and incidence of pulmonary exacerbation in adult and pediatric cystic fibrosis patients.
- Trial name
- NCT00060801
- Testing
- BIIL 283 BS (Amelubent)
- Where
- 35 sites in United States
- Volunteers
- 420 people
- Sponsor
- Boehringer Ingelheim
Type 1 Diabetes Mellitus
Study of Secukinumab in Patients With Newly-diagnosed Type 1 Diabetes Mellitus
This study will assess the safety and efficacy of secukinumab on the preservation of pancreatic beta cells in patients with newly-diagnosed type 1 diabetes mellitus.
- Trial name
- NCT02044848
- Testing
- Secukinumab
- Where
- 2 sites in United States
- Volunteers
- 5 people
- Sponsor
- Novartis Pharmaceuticals
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
Acute Lymphoblastic Leukemia
Clofarabine in Chinese Pediatric Patients With Refractory or Relapsed Acute Lymphoblastic Leukemia
Outcomes for children with relapsed/refractory (R/R) acute lymphoblastic leukemia (ALL) are dismal. Therefore, the investigators performed this multicenter, phase II study to evaluate the efficacy and , safety and pharmacokinetic…
- Trial name
- NCT02544789
- Testing
- Clofarabine
- Where
- 6 sites in China
- Volunteers
- 44 people
- Sponsor
- Betta Pharmaceuticals Co., Ltd.
T-cell Acute Lymphoblastic Leukemia, T-lymphoblastic Lymphoma
A Study of Anti-CD7 CAR-T Cells in Pediatric and Young Adult Patients With Relapse and Refractory T-ALL/ T-LBL
T cells are a type of immune cell. Like other cells of the body, T Cells can develop cancer. T cell cancers mainly include T cell leukaemia and T cell lymphoma, both of which have a relatively poor prognosis.
- Trial name
- NCT04860817
- Testing
- Target CD7 CAR-T cells
- Where
- China
- Sponsor
- 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China
Hypotension
Dose-response Study of Sodium Nitroprusside in Children Requiring Controlled Hypotension in the Operating Room
Sodium nitroprusside (SNP) has been approved for control of blood pressure in adults, yet there are no controlled studies in children.
- Trial name
- NCT00135668
- Testing
- Nitroprusside
- Where
- United States
- Volunteers
- 211 people
- Sponsor
- The Emmes Company, LLC
Bladder, Neurogenic
Study to Evaluate the Efficacy and Safety of Tamsulosin in Children With Neurogenic Bladder
Aim of this study is to evaluate the efficacy and safety of a range of doses of tamsulosin hydrochloride as treatment in children with an elevated detrusor leak point pressure associated with a known neurological deficit
- Trial name
- NCT00796614
- Testing
- tamsulosin hydrochloride
- Where
- 52 sites in United States, Belgium and 11 more
- Volunteers
- 231 people
- Sponsor
- Boehringer Ingelheim
Major Depressive Disorder
Efficacy, Safety, and Tolerability of Levomilnacipran ER in Pediatric Patients (7-17 Years) With Major Depressive Disorder
The objective of this study is to evaluate the efficacy, safety, and tolerability of levomilnacipran compared with placebo in pediatric outpatients (7-17 years) with major depressive disorder (MDD).
- Trial name
- NCT03569475
- Testing
- Levomilnacipran ER, Fluoxetine
- Where
- 51 sites in United States
- Volunteers
- 501 people
- Sponsor
- Allergan
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