Clinical trials: Pediatric Disease
Familial Hypercholesterolemia - Heterozygous
Study to Evaluate Efficacy and Safety of Inclisiran in Children With Heterozygous Familial Hypercholesterolemia
This is a pivotal phase III study designed to evaluate safety, tolerability, and efficacy of inclisiran in children (aged 6 to <12 years) with heterozygous familial hypercholesterolemia (HeFH) and elevated low density lipoprotein…
- Trial name
- ORION-20 (NCT06597019)
- Testing
- Inclisiran
- Where
- 66 sites in United States, Argentina and 21 more
- Volunteers
- 60 people
- Sponsor
- Novartis Pharmaceuticals
Growth Hormone Deficiency
Phase 2 Study of LUM-201 in Children With Growth Hormone Deficiency (OraGrowtH210 Trial)
This is a multi-national trial. The goals of the trial are to study LUM-201 as a possible treatment for Pediatric Growth Hormone Deficiency (PGHD) and investigate a predictive enrichment marker (PEM) strategy to select subjects…
- Trial name
- OraGrowtH210 (NCT04614337)
- Testing
- LUM-201, rhGH Norditropin® pen (34 µg/kg)
- Where
- 43 sites in United States, Australia and 4 more
- Volunteers
- 104 people
- Sponsor
- Lumos Pharma
Colitis, Ulcerative
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- PURSUIT 2 (NCT03596645)
- Testing
- Golimumab, Infliximab
- Where
- 58 sites in United States, Belgium and 9 more
- Volunteers
- 84 people
- Sponsor
- Janssen Research & Development, LLC
Atypical Hemolytic Uremic Syndrome
A Study Evaluating the Efficacy, Safety, Pharmacokinetics and Pharmacodynamics of Crovalimab in Pediatric Participants With Atypical Hemolytic Uremic Syndrome (aHUS)
This study aims to evaluate the efficacy and safety of crovalimab in pediatric participants with aHUS.
- Trial name
- COMMUTE-p (NCT04958265)
- Testing
- Crovalimab
- Where
- 20 sites in United States, Belgium and 8 more
- Volunteers
- 41 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab.
- Trial name
- SHINE-1 (NCT04004611)
- Testing
- Mirikizumab
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
Psoriasis
An Efficacy, Safety, and Pharmacokinetics Study of Subcutaneously Administered Ustekinumab in the Treatment of Moderate to Severe Chronic Plaque Psoriasis in Pediatric Participants Greater Than or Equal to 6 to Less Than 12 Years of Age
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in pediatric participants aged greater than or equal to (>=) 6 through less than (<) 12 years with moderate to severe chronic plaque psoriasis
- Trial name
- CADMUS Jr (NCT02698475)
- Testing
- Ustekinumab 0.75 mg/kg, Ustekinumab 45 mg, Ustekinumab 90 mg
- Where
- 31 sites in United States, Belgium and 7 more
- Volunteers
- 44 people
- Sponsor
- Janssen Research & Development, LLC
Angelman Syndrome
A Study of the Safety and Tolerability of GTX-102 in Children With Angelman Syndrome
The primary objective of the study is to evaluate the safety and tolerability of multiple-ascending doses of GTX-102 administered by intrathecal (IT) injection to participants with Angelman Syndrome (AS).
- Trial name
- NCT04259281
- Testing
- GTX-102
- Where
- 25 sites in United States, Australia and 6 more
- Volunteers
- 74 people
- Sponsor
- Ultragenyx Pharmaceutical Inc
Hearing Loss, Conductive, Hearing Loss, Mixed
Pediatric Expansion Study of the Sentio System
This study is performed to collect safety and performance data supporting the use of the Sentio system in children below 12 years of age. The system is currently available on the market for patients 12 years and above.
- Conditions
- Hearing Loss, Conductive, Hearing Loss, Mixed, Single Sided Deafness
- Trial name
- BC119 (NCT06976086)
- Testing
- Active transcutaneous bone conduction system
- Where
- 8 sites in Netherlands, Spain and 1 more
- Volunteers
- 50 people
- Sponsor
- Oticon Medical
Rhinitis, Allergic, Perennial
Perennial Allergic Rhinitis In Pediatric Subjects
To assess the safety of long-term use of cetirizine dry syrup in children with perennial allergic rhinitis.
- Trial name
- NCT00257595
- Testing
- Cetirizine Dry Syrup
- Volunteers
- 30 people
- Sponsor
- GlaxoSmithKline
Muscular Dystrophy, Duchenne
An Open-Label Extension Study for Patients With Duchenne Muscular Dystrophy Who Participated in Studies of SRP-5051 (Vesleteplirsen)
The purpose of this extension study is to evaluate the safety, tolerability, and pharmacokinetics of repeat administrations of SRP-5051 (vesleteplirsen) in participants with Duchenne muscular dystrophy (DMD) who participated in…
- Trial name
- NCT03675126
- Testing
- SRP-5051
- Where
- 8 sites in United States, Canada
- Volunteers
- 15 people
- Sponsor
- Sarepta Therapeutics, Inc.
Atopic Dermatitis
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
Open-Label Study designed to evaluate the HPA axis suppression potential of Clobetasol Topical Oil and pharmacokinetic safety / systemic exposure to clobetasol when Clobetasol Topical Oil is applied to pediatric subjects with…
- Trial name
- NCT03847389
- Testing
- Clobetasol propionate 0.05% Topical Oil
- Where
- 6 sites in United States
- Volunteers
- 8 people
- Sponsor
- Hill Dermaceuticals, Inc.
Atopic Dermatitis
Open-Label Study of RVT-501 Topical Ointment in Pediatric Patients With Atopic Dermatitis
This is a multicenter, open-label Phase 1b study in pediatric patients age 2-11 years old with extensive atopic dermatitis.
- Trial name
- NCT03415282
- Testing
- RVT-501 0.5% topical ointment
- Where
- 12 sites in United States
- Volunteers
- 24 people
- Sponsor
- Dermavant Sciences GmbH
X-linked Hypophosphatemic Rickets/Osteomalacia
A Study of KRN23 in Pediatric Patients With X-linked Hypophosphatemic Rickets/Osteomalacia
Before switching to the post-marketing study: To evaluate the efficacy and safety of KRN23 administered subcutaneously once every 2 weeks in children with X-linked hypophosphatemic rickets/osteomalacia(XLH).
- Trial name
- NCT03233126
- Testing
- KRN23
- Where
- 4 sites in Japan
- Volunteers
- 16 people
- Sponsor
- Kyowa Kirin Co., Ltd.
Measles, Mumps
Immunogenicity and Safety of Hepatitis A Vaccine Given at the Same Time of Measles, Mumps, Rubella Combined Vaccine
The present study will explore the immunogenicity of AVAXIM™ 80U-Pediatric in 12-13 months Turkish children and check if the administration of the MMR trivalent vaccine on the same day but at different site will interfere on…
- Conditions
- Measles, Mumps, Rubella, Hepatitis A
- Trial name
- NCT00313950
- Testing
- Inactivated Hep A vaccine; Attenuated Measles Mumps Rubella, Attenuated Measles Mumps Rubella; Inactivated Hep A vaccine
- Where
- Turkey (Türkiye)
- Volunteers
- 470 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Bronchospasm, Activity/Exercise Induced Bronchospasm
A Study Measuring Asthma Control In Pediatric And Adolescent Subjects Whose Asthma Is Worsened By Activity Or Exercise
During this study, your child will need to attend up to 5 office visits and maintain regular telephone contact with the clinic. Certain office visits will include physical exams, medical history review, exercise challenge test…
- Trial name
- NCT00118690
- Testing
- Fluticasone propionate/salmeterol
- Where
- 51 sites in United States
- Volunteers
- 227 people
- Sponsor
- GlaxoSmithKline
Niemann-Pick Diseases, Acid Sphingomyelinase Deficiency
A Real-world Long-term Safety and Immunogenicity Study of Olipudase Alfa Therapy in Pediatric Patients Less Than 2 Years of Age With Acid Sphingomyelinase Deficiency (ASMD)
US, multicenter, cohort, open label observational study with primary data collection. Ancillary protocol-specified procedures to address the study objectives (eg, assessment of ADA) may be considered outside the standard of care…
- Trial name
- NCT06192576
- Testing
- Olipudase alfa
- Where
- 6 sites in United States
- Volunteers
- 10 people
- Sponsor
- Sanofi
Developmental Disabilities
Feeding Trial in Pediatric Patients
This is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities.
- Trial name
- NCT01469117
- Testing
- enteral formula
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Société des Produits Nestlé (SPN)
Glaucoma
A Phase 3 Prospective, Randomized, Double-Masked, 12-Week, Parallel Group Study In Pediatric Subjects With Glaucoma.
To assess the effectiveness of latanoprost 0.005% ophthalmic solution dosed once-daily and timolol 0.5% dosed twice-daily in paediatric subjects of 18 years of age or under who are diagnosed with glaucoma.
- Trial name
- NCT00716859
- Testing
- Timolol, latanoprost
- Where
- 48 sites in United States, Belgium and 18 more
- Volunteers
- 139 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Gastroesophageal Reflux Disease (GERD), Erosive Esophagitis
Esomeprazole for Treatment of GERD in Pediatric Patients
To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease…
- Conditions
- Gastroesophageal Reflux Disease (GERD), Erosive Esophagitis, Non-erosive Esophagitis
- Trial name
- NCT00228527
- Testing
- Esomeprazole (Nexium)
- Where
- 36 sites in United States, Belgium and 2 more
- Volunteers
- 100 people
- Sponsor
- AstraZeneca
Hypertension
A Study to Evaluate the Safety/Tolerability and Pharmacokinetics of Aliskiren in Hypertensive Pediatric and Adolescent Patients 6-17 Years of Age
This first open-label study in a pediatric population was designed to evaluate aliskiren safety and pharmacokinetics after single and multiple dosing in 6-17 year old children with hypertension.
- Trial name
- NCT00834041
- Testing
- Aliskiren 3.125 mini-tablets
- Where
- 5 sites in United States, Belgium and 3 more
- Volunteers
- 39 people
- Sponsor
- Novartis
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