Clinical trials: Disorder, Pediatric
Healthy Volunteers
A Safety Study of Mebendazole in Children 2 to 10 Years of Age
The purpose of this study is to assess the safety and tolerability of mebendazole 500-mg chewable tablet formulation in a pediatric population.
- Trial name
- NCT01173562
- Testing
- Mebendazole
- Where
- Tanzania
- Volunteers
- 397 people, healthy volunteers welcome
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Hemophilia B
Post-Marketing Surveillance (Usage Results Study) of RIXUBIS in Adult and Pediatric Patients With Haemophilia B in South Korea
Primary: To characterize the safety of RIXUBIS when used under normal clinical care in South Korea. Secondary: To describe hemostatic effectiveness in subjects receiving RIXUBIS under normal clinical care in South Korea.
- Trial name
- NCT02922231
- Testing
- RIXUBIS
- Where
- 5 sites in South Korea
- Volunteers
- 57 people
- Sponsor
- Baxalta now part of Shire
Short Bowel Syndrome
Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study
The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period.
- Trial name
- NCT02949362
- Testing
- Teduglutide, SOC
- Where
- 11 sites in United States, United Kingdom
- Volunteers
- 29 people
- Sponsor
- Shire
Asthma
Efficacy and Safety of Ciclesonide (CIC) Administered Twice Daily in Pediatric Patients With Asthma.
Primary objective: To demonstrate the efficacy of ciclesonide, compared to placebo, at 80 μg twice daily (BID) or 40 μg BID for 12 weeks in patients with persistent asthma.
- Trial name
- NCT00392288
- Testing
- Ciclesonide
- Where
- 6 sites in United States, Hungary and 4 more
- Volunteers
- 528 people
- Sponsor
- AstraZeneca
Cartilage Disease
Non-interventional Study in Pediatric Patients Treated With NOVOCART Inject in the Knee
The study is a prospective, multicenter, single-arm non-interventional study to evaluate the efficacy, safety and health economics of NOVOCART® Inject in the treatment of cartilage defects of the knee in pediatric patients with…
- Trial name
- NINJA (NCT05391841)
- Testing
- NOVOCART Inject
- Where
- 6 sites in Germany
- Sponsor
- Tetec AG
Acute Renal Failure (ARF), Acute Kidney Injury (AKI)
Retrospective Analysis of Prismaflex HF20 Set Versus ppCRRT Registry
A retrospective multicenter, observational design intended to capture data on pediatrics (weighing between 8 - 20 kg) who underwent continuous renal replacement therapy (CRRT) using the HF20 set.
- Conditions
- Acute Renal Failure (ARF), Acute Kidney Injury (AKI), Fluid Overload in Dialysis Patients
- Trial name
- NCT06633029
- Testing
- Prismaflex HF20
- Where
- 5 sites in United States
- Volunteers
- 59 people
- Sponsor
- Vantive Health LLC
Hearing Loss, Ear Diseases
Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
This is a prospective within-subjects repeated-measures study that will enroll 17 users 13 years or older implanted with a HiResolution Bionic Ear System.
- Conditions
- Hearing Loss, Ear Diseases, Hearing Disorders, Otolaryngological Disease
- Trial name
- NCT05034731
- Testing
- Remote Fitting, In-Office Fitting
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Advanced Bionics
Hearing Loss, Conductive Hearing Loss
Evaluation of the Ponto Bone Anchored Hearing System in a Pediatric Atresia Population
The purpose of this study is to in a proactive manner collect high quality data from a pediatric patients who have undergone a bone anchored hearing solution, using the Ponto BHX implant, in clinical practice.
- Conditions
- Hearing Loss, Conductive Hearing Loss, Atresia
- Trial name
- NCT03723161
- Testing
- Bone Achored Hearing surgery
- Where
- Sweden
- Volunteers
- 15 people
- Sponsor
- Oticon Medical
Hemophilia B
Evaluation of a Recombinant Factor IX Product, APVO101, in Previously-Treated Pediatric Patients With Hemophilia B
Phase 3/4, single arm, open-label study to evaluate PK, safety, and efficacy of APVO101 prophylaxis in severe or moderately severe hemophilia B subjects < 12 years of age.
- Trial name
- NCT03855280
- Testing
- APVO101
- Where
- 11 sites in Brazil, Georgia and 4 more
- Volunteers
- 21 people
- Sponsor
- Medexus Pharma, Inc.
Atopic Dermatitis
Long-term Trial of OPA-15406 Ointment in Adult and Pediatric Patients With Atopic Dermatitis
To demonstrate the safety of 1% OPA-15406 ointment in adult patients with AD and of 0.3% and 1% OPA-15406 ointments in pediatric patients with AD administered twice daily for 52 weeks.
- Trial name
- NCT03961529
- Testing
- 0.3% OPA-15406 ointment, 1% OPA-15406 ointment
- Where
- Japan
- Volunteers
- 366 people
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
Pediatrics, Muscle Spasticity
BOTOX® Treatment in Pediatric Upper Limb Spasticity
This study will evaluate the safety and efficacy of BOTOX® (botulinum toxin Type A) in pediatric patients with upper limb spasticity.
- Conditions
- Pediatrics, Muscle Spasticity, Cerebral Palsy, Stroke
- Trial name
- NCT01603602
- Testing
- botulinum toxin Type A
- Where
- 45 sites in United States, Canada and 7 more
- Volunteers
- 235 people
- Sponsor
- Allergan
Atopic Dermatitis
A Study to Observe How Pediatric Patients With Severe Atopic Dermatitis Despite Less Extensive Skin Lesions Respond to Dupilumab Treatment
In adolescents treated with dupilumab, clinical trials showed significant improvement of atopic dermatitis (AD) signs and symptoms, with a good safety profile.
- Trial name
- AD-BEASCUITS (NCT06192563)
- Testing
- Dupilumab
- Where
- 9 sites in Italy
- Volunteers
- 230 people
- Sponsor
- Sanofi
Ulcerative Colitis, Crohn's Disease
Vedolizumab IV in Pediatric Participants With Ulcerative Colitis (UC) or Crohn's Disease (CD)
The purpose of this study is to evaluate vedolizumab pharmacokinetics (PK), safety and tolerability in pediatric participants with moderately to severely active UC or CD.
- Trial name
- NCT03138655
- Testing
- Vedolizumab
- Where
- 88 sites in United States, Belgium and 9 more
- Volunteers
- 89 people
- Sponsor
- Takeda
Steroid Refractory Acute Graft Versus Host Disease
Methoxsalen and Extracorporeal Photopheresis (ECP) for the Treatment of Pediatric Participants With Steroid Refractory Acute Graft Versus Host Disease
This is a single-arm, open-label, multicenter study of the efficacy of UVADEX® (methoxsalen) Sterile Solution in conjunction with THERAKOS® CELLEX® Photopheresis Systems (ECP) in pediatric participants with steroid-refractory…
- Trial name
- NCT02524847
- Testing
- Methoxsalen, Extracorporeal Photopheresis (ECP)
- Where
- 32 sites in United States, Austria and 6 more
- Volunteers
- 29 people
- Sponsor
- Therakos, Inc., a Mallinckrodt Company
Recurrent Malignant Glioma
Phase I/II Trial of Intracerebral IL13-PE38QQR Infusions in Pediatric Patients With Recurrent Malignant Glioma
IL13-PE38QQR is an oncology drug product consisting of IL13 (interleukin-13) and PE38QQR (a bacteria toxin). IL3-PE38QQR is a protein that exhibits cell killing activity against a variety of IL13-receptor positive tumor cell…
- Trial name
- NCT00378235
- Testing
- IL13-PE38QQR
- Where
- 10 sites in United States
- Sponsor
- INSYS Therapeutics Inc
Solid Tumors, Hepatocellular Carcinoma (HCC)
A Phase I, First in Human Study of CBA-1205, Anti-DLK1 Monoclonal Antibody in Patients With Advanced Solid Tumors, Hepatocellular Carcinoma (HCC), Melanoma, and Pediatric Cancer
In this first-in-human, muticenter, non-randomized, open-label, standard 3+3 dose escalation Phase I study encompasses 5 parts (Part 1-5).
- Conditions
- Solid Tumors, Hepatocellular Carcinoma (HCC), Malignant Melanoma, Pediatric Cancer
- Trial name
- NCT06636435
- Testing
- CBA-1205 Part 1, CBA-1205 Part 2, CBA-1205 Part 3
- Where
- 5 sites in Japan
- Volunteers
- 66 people
- Sponsor
- Chiome Bioscience Inc.
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
Type 1 Diabetes
In Clinic Evaluation of the PLGM Feature
This study is a multi-center, single arm and in-clinic study to evaluate the safety of the PLGM System and its algorithm with the Enlite 3 Sensor.
- Trial name
- PLGM (NCT02130284)
- Testing
- Predictive Low Glucose Management Feature in Insulin pump
- Where
- 8 sites in United States
- Volunteers
- 80 people
- Sponsor
- Medtronic MiniMed, Inc.
Bronchial Asthma
Fasenra Pediatric Japan Post-Marketing Study(PMS)
The purpose of the investigation is to confirm the followings under the post-marketing actual use of Fasenra® Subcutaneous Injection 30 mg / 10mg Syringe (hereinafter referred to as Fasenra). 1.
- Trial name
- NCT06427876
- Where
- 9 sites in Japan
- Volunteers
- 40 people
- Sponsor
- AstraZeneca
Irritable Bowel Syndrome
A Study Evaluating Oral Eluxadoline Administered to Pediatric Participants With Irritable Bowel Syndrome With Diarrhea (IBS-D)
This study will assess the long-term safety of oral Eluxadoline administered to pediatric participants with IBS-D who have completed study intervention in the Phase 2 study 3030-202-002 or the Phase 3 study 3030-303-002.
- Trial name
- NCT04880876
- Testing
- 25mg Eluxadoline, 100mg Eluxadoline
- Where
- 6 sites in United States
- Volunteers
- 124 people
- Sponsor
- AbbVie
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