Clinical trials: Pediatric Disease
Growth Disorders
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in the UK
This is a National, Multicentre, Observational Registry to study Adherence and Long Term Outcomes of Therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospital in the UK and…
- Trial name
- ECOS UK (NCT01263457)
- Testing
- Easypod
- Where
- 6 sites in United Kingdom
- Volunteers
- 191 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Pmm2-CDG, Phosphomannomutase 2 Deficiency
24-Week Study to Assess the PD, Safety, Tolerability, and PK of GLM101 in Participants With PMM2-CDG
This is a Phase 2, randomized, open-label, 24-week treatment study to evaluate the potential pharmacodynamic (PD) activity, safety, tolerability, and pharmacokinetics (PK) of GLM101 in adult, adolescent, and pediatric, patients…
- Trial name
- NCT05549219
- Testing
- GLM101
- Where
- 4 sites in United States, Spain and 1 more
- Volunteers
- 27 people
- Sponsor
- Glycomine, Inc.
Infectious Diseases
BAY 0 9867 Cipro Pediatric Use Study (QUIP)
Objective and subjective musculoskeletal evaluations will be performed to determine differences in the ciprofloxacin versus non-quinolone treated pediatric patients so that we can tell what the natural occurrence of such…
- Trial name
- NCT00761462
- Testing
- Ciprofloxacin, Non-quinolone antibiotic
- Where
- 67 sites in United States, Canada
- Volunteers
- 1,029 people
- Sponsor
- Bayer
Infection, Bacterial, Infection Viral
Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral…
- Trial name
- NCT06379061
- Testing
- Adult and Pediatrics
- Where
- 4 sites in United States
- Volunteers
- 650 people
- Sponsor
- Beckman Coulter, Inc.
Asthma
Safety and Blood Level Study of Unit Dose Budesonide
The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.
- Trial name
- UDB P101 (NCT00627679)
- Testing
- Budesonide Inhalation Suspension, MAP0010 low dose, MAP0010 intermediate dose
- Where
- Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Allergan
Psoriasis Vulgaris, Psoriatic Arthritis
Special Drug Use-results Survey to Evaluate Safety and Efficacy of Cosentyx in Pediatric Patients With PsV, PsA, or GPP
This was a multicenter, centrally registered observational study without a control group. This observational study was a specified drug use-results survey conducted under GPSP to collect information on safety and efficacy during…
- Conditions
- Psoriasis Vulgaris, Psoriatic Arthritis, Pustular Psoriasis
- Trial name
- NCT05215561
- Testing
- Cosentyx
- Where
- 21 sites in Japan
- Volunteers
- 36 people
- Sponsor
- Novartis Pharmaceuticals
Japanese Encephalitis
Open-label, Randomized Study in a Pediatric Population in a JEV (Japanese Encephalitis Virus)-Endemic Country
This is a randomized, open-label Phase 3 study including children aged >9 months to <17 years and 7 months who have been vaccinated with IXIARO in study IC51-323.
- Trial name
- NCT01296360
- Testing
- IXIARO
- Where
- 3 sites in Philippines
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Conjunctivitis
Safety and Efficacy of Zylet vs Lotemax, Tobramycin and Vehicle in Pediatric Blepharoconjunctivitis
The objective of this study is to evaluate the safety and effectiveness of Zylet in comparison with Lotemax, Tobramycin and the vehicle of Zylet for the treatment of blepharoconjunctivitis in pediatric subjects.
- Trial name
- NCT00705159
- Testing
- loteprednol etabonate and tobramycin, loteprednol etabonate, Tobramycin
- Where
- United States
- Volunteers
- 137 people
- Sponsor
- Bausch & Lomb Incorporated
Generalized Lipodystrophy
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
This study is researching a new drug called mibavademab (called "study drug"). The study involves participants with a condition called Generalized Lipodystrophy (GLD).
- Trial name
- LAGO (NCT07220785)
- Testing
- Mibavademab
- Where
- 9 sites in United States, Brazil and 1 more
- Volunteers
- 28 people
- Sponsor
- Regeneron Pharmaceuticals
Hypercholesterolemia
Bioequivalence Study On Pediatric Appropriate Formulation
To determine bioequivalence of a atorvastatin pediatric formulation comparing to the 10 mg commercial atorvastatin calcium tablet formulation.
- Trial name
- NCT00777517
- Testing
- Lipitor, Atorvastatin pediatric formulation
- Where
- Singapore
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Cytomegalovirus Infections, Heart Transplantation
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.
- Trial name
- NCT01165580
- Testing
- valganciclovir [Valcyte]
- Where
- 19 sites in United States, Canada and 1 more
- Volunteers
- 17 people
- Sponsor
- Hoffmann-La Roche
Asthma, Bronchoconstriction
Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol in Pediatric Subjects
The purpose of this study is to investigate, using an exercise challenge approach, the dose response of levalbuterol HFA MDI in pediatric subjects with asthma
- Trial name
- NCT00685347
- Testing
- Levalbuterol HFA MDI, Racemic Albuterol
- Where
- 6 sites in United States
- Volunteers
- 33 people
- Sponsor
- Sumitomo Pharma America, Inc.
B-cell Acute Lymphoblastic Leukemia
Study of Tisagenlecleucel in Chinese Pediatric and Young Adult Subjects With Relapsed or Refractory B-cell ALL
This is a single arm, multi-center, phase II study to evaluate the efficacy and safety of tisagenlecleucel in Chinese pediatric and young adult subjects with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL)
- Trial name
- NCT04156659
- Testing
- Tisagenlecleucel
- Sponsor
- Novartis Pharmaceuticals
Encephalitis
Safety and Immunogenicity of the Japanese Encephalitis Vaccine IC51 (IXIARO®) in a Pediatric Population
The primary objective is to assess the systemic and local safety profile of purified inactivated Japanese Encephalitis Virus (JEV) vaccine IC51 administered in two doses in a 28 days interval up to Month 7 after the first IC51…
- Trial name
- NCT01041573
- Testing
- IC51 Japanese Encephalitis, Havrix®720, Prevnar
- Where
- 2 sites in Philippines
- Volunteers
- 1,869 people, healthy volunteers welcome
- Sponsor
- Valneva Austria GmbH
Type 1 Diabetes
Evaluation of the MiniMed™ 780G System in Type 1 Adult and Pediatric Subjects Utilizing Insulin Fiasp®
This global study (US, Canada, and Australia) will evaluate the safety and effectiveness of the MiniMed 780G system in type 1 adult and pediatric subjects utilizing Fiasp (insulin aspart injection) in a home setting.
- Trial name
- NCT05224258
- Testing
- MiniMed 780G System
- Where
- 18 sites in United States, Australia and 1 more
- Volunteers
- 240 people
- Sponsor
- Medtronic MiniMed, Inc.
Autism, Autistic Disorder
Safety and Efficacy Study in the Treatment of Intestinal Problems Associated With Autism
The purpose of this study is to determine if human immunoglobulin given by mouth twice a day is effective in treating the persistent gastrointestinal (GI) problems such as diarrhea, constipation, abdominal pain, and bloating, in…
- Conditions
- Autism, Autistic Disorder, Child Development Disorders, Pervasive, Gastrointestinal Diseases
- Trial name
- NCT00110708
- Testing
- Oralgam (human immunoglobulin)
- Where
- 22 sites in United States
- Volunteers
- 120 people
- Sponsor
- PediaMed Pharmaceuticals
Growth Disorders
To Assess the Level of Adherence of Subjects Receiving SAIZEN® Via Easypod™ in France
This is a National, Multicentre, Observational Registry to study adherence and long term outcomes of therapy in paediatric subjects using Easypod™ electromechanical device for growth hormone treatment from hospitals in France and…
- Trial name
- ECOS FRA (NCT01291394)
- Testing
- Easypod™
- Where
- France
- Volunteers
- 223 people
- Sponsor
- Merck KGaA, Darmstadt, Germany
Type 2 Spinal Muscular Atrophy
Efficacy and Safety of Intrathecal OAV101 (AVXS-101) in Pediatric Patients With Type 2 Spinal Muscular Atrophy (SMA)
This was a Phase III multi-center, single dose (1.2 x 10^14 vector genomes), randomized, sham controlled, double-blind study that investigates the efficacy, safety and tolerability of OAV101B in treatment naive, sitting and never…
- Trial name
- STEER (NCT05089656)
- Testing
- OAV101
- Where
- 42 sites in United States, Brazil and 11 more
- Volunteers
- 126 people
- Sponsor
- Novartis Pharmaceuticals
Anemia Associated With Chronic Kidney Disease
Investigating the Efficacy, Safety and PK of Roxadustat (FG-4592) for Treatment of Anemia in Pediatric Patients With CKD
This open-labeled, multicenter study is designed to evaluate the efficacy, safety and PK/PD of roxadustat in ESA-naïve and ESA-treated pediatric patients with CKD Stages 3, 4, and 5, as well as end-stage renal disease (ESRD) who…
- Trial name
- NCT04621331
- Testing
- Roxadustat
- Where
- 4 sites in United States
- Sponsor
- Kyntra Bio
Hypercholesterolemia
A Clinical Study in Children With Heterozygous Familial Hypercholesterolemia (HeFH) Aged 6 to 17 Treated Once Daily With Bempedoic Acid Oral Dosing (CLEAR Path 1)
Multiple-dose study to measure pharmacokinetics, pharmacodynamics and safety of bempedoic acid in pediatric participants 6 to 17 years of age with HeFH.
- Trial name
- CLEAR Path 1 (NCT05694260)
- Testing
- Bempedoic acid
- Where
- 24 sites in United States, Canada and 4 more
- Volunteers
- 31 people
- Sponsor
- Esperion Therapeutics, Inc.
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