Clinical trials: Pediatric Gastrointestinal Disorders
Chronic Hepatitis B
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of…
- Trial name
- NCT00095121
- Testing
- Adefovir Dipivoxil (ADV), Lamivudine
- Where
- United States
- Volunteers
- 173 people
- Sponsor
- Gilead Sciences
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.
Crohn's Disease
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
- Trial name
- NCT00409682
- Testing
- Adalimumab
- Where
- 45 sites in United States, Belgium and 6 more
- Volunteers
- 192 people
- Sponsor
- Abbott
Hepatitis B, Chronic
A Study of Entecavir in Pediatric Patients With Chronic Hepatitis B Virus (HBV)-Infection
The purpose of this clinical study is to determine the appropriate doses of entecavir to use in children and adolescents. Safety, tolerability and efficacy will also be studied
- Trial name
- NCT00423891
- Testing
- Entecavir
- Where
- 19 sites in United States, Argentina and 6 more
- Volunteers
- 64 people
- Sponsor
- Bristol-Myers Squibb
Diphtheria, Tetanus
Antibody Persistence at Age 3.5 and 4.5 Years After Primary and Booster DTaP-IPV-Hep B-PRP~T or Infanrix Hexa Vaccination
This is a follow-up of the primary series vaccination schedule in Study A3L24 (NCT01177722) and booster vaccination in Study A3L27 (NCT01444781).
- Conditions
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
- Trial name
- NCT01983540
- Testing
- DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine, DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine, Infanrix hexa + Prevenar + Rotarix vaccine
- Where
- 2 sites in Colombia, Costa Rica
- Volunteers
- 558 people, healthy volunteers welcome
- Sponsor
- Sanofi Pasteur, a Sanofi Company
Esophagitis
Protonix Treatment of Maintenance of Healing in Pediatric Participants Aged 1-11 Years and 12-17 Years
The purpose of this study is to explore the outcomes, tolerability and safety of 2 different doses of oral pantoprazole (full healing dose, half healing dose), assigned based upon weight, for the maintenance of healing of erosive…
- Trial name
- NCT04821310
- Where
- 27 sites in United States, Bosnia and Herzegovina and 7 more
- Volunteers
- 43 people
- Sponsor
- Pfizer
Diarrhea, Gastroenteritis
Rifaximin 200 mg Plus Oral Rehydration vs Oral Rehydration Alone in Children With Acute Diarrhea
The goal of this clinical trial is to learn how rifaximin 200 mg is processed in the body (pharmacokinetics) in children 6 to 11 years old with acute diarrhea that may be caused by bacteria.
- Conditions
- Diarrhea, Gastroenteritis, Bacterial Infection, Acute Diarrhea
- Trial name
- NCT07285785
- Testing
- Rifaximin 200 mg Tablet, Oral Rehydration Therapy (ORT)
- Where
- 10 sites in United States
- Volunteers
- 54 people
- Sponsor
- Bausch Health Americas, Inc.
Colitis, Ulcerative
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction…
- Trial name
- QUASAR Jr (NCT06260163)
- Testing
- Guselkumab Subcutaneous, Guselkumab Intravenous
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
Essential Fatty Acid Deficiency (EFAD)
Pediatric Study to Evaluate Risk of Developing Essential Fatty Acid Deficiency When Receiving Clinolipid or Standard-of-Care Lipid Emulsion (Part A)
This will be a descriptive study designed to evaluate the propensity for hospitalized pediatric patients treated adequately with Clinolipid or standard of care (Intralipid) from 7 up to 90 days to develop Essential Fatty Acid…
- Trial name
- NCT04555044
- Testing
- Clinolipid, Intralipid
- Where
- 9 sites in United States
- Volunteers
- 101 people
- Sponsor
- Baxter Healthcare Corporation
Medullary Thyroid Cancer, Infantile Myofibromatosis
A Study of Oral LOXO-292 (Selpercatinib) in Pediatric Participants With Advanced Solid or Primary Central Nervous System (CNS) Tumors
This is an open-label, multi-center Phase 1/2 study of oral LOXO-292 in pediatric participants with an activating rearranged during transfection (RET) alteration and an advanced solid or primary CNS tumor.
- Conditions
- Medullary Thyroid Cancer, Infantile Myofibromatosis, Infantile Fibrosarcoma, Papillary Thyroid Cancer
- Trial name
- LIBRETTO-121 (NCT03899792)
- Testing
- Selpercatinib
- Where
- 26 sites in United States, Australia and 9 more
- Volunteers
- 36 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- SHINE-2 (NCT05784246)
- Testing
- Mirikizumab IV, Mirikizumab SC
- Where
- 34 sites in United States, Belgium and 9 more
- Volunteers
- 63 people
- Sponsor
- Eli Lilly and Company
Hepatitis C
An Open-Label Study of the Effect of Telaprevir in Combination With Peginterferon Alfa-2b and Ribavirin in Pediatric Subjects Infected With Hepatitis C Virus
The purpose of this study is to assess the safety, efficacy, and pharmacokinetics in a carefully monitored cohort of pediatric subjects infected with hepatitis C virus (HCV) on a telaprevir-based regimen in Part A and with dose…
- Trial name
- NCT01701063
- Testing
- Telaprevir, Peginterferon alfa-2b, Ribavirin
- Where
- 23 sites in United States, Belgium and 4 more
- Volunteers
- 42 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Exocrine Pancreatic Insuficiency
Determine the Prevalence of Exocrine Pancreatic Insufficiency (EPI) in Pediatric and Adult Participants With Alagille Syndrome After Liver Transplantation
The goal of this clinical trial is to determine the prevalence of exocrine pancreatic insufficiency (EPI) in a population of pediatric and adult participants with Alagille Syndrome (ALGS) post liver transplant.
- Trial name
- NCT07335523
- Testing
- Fecal Fat
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Digestive Care, Inc.
Liver Diseases, Hepatitis, Chronic
Epidemiological Study in Children and Adolescents With Chronic Hepatitis B
The purpose of this study is to collect epidemiological data in children and adolescents with chronic hepatitis B(CHB), in particular data on the prevalence of HBeAg positive disease with associated ALT levels , active HBeAg…
- Conditions
- Liver Diseases, Hepatitis, Chronic, Hepatitis, Viral, Human, Hepatitis
- Trial name
- EPIC B (NCT01163240)
- Where
- 86 sites in United States, Argentina and 16 more
- Volunteers
- 1,640 people
- Sponsor
- Novartis Pharmaceuticals
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
Ulcerative Colitis
A Study Evaluating the Effects of Filgotinib in Children and Teenagers With Ulcerative Colitis
The aim of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of filgotinib as a treatment for UC in children and adolescents aged from 8 to less than 18 years.
- Trial name
- Galapeduca (NCT06865417)
- Testing
- Filgotinib
- Where
- 46 sites in Belgium, Croatia and 11 more
- Volunteers
- 80 people
- Sponsor
- Alfasigma S.p.A.
Gastroesophageal Reflux Disease (GERD)
A Study of the Safety and Effectiveness of Rabeprazole for the Treatment of Gastroesophageal Reflux Disease (GERD) in Pediatric Patients
The purpose of the study is to access the effectiveness and safety of oral rabeprazole in the treatment of acid-related disorders in pediatric patients, focusing specifically on the manifestation of GERD (symptomatic and erosive…
- Trial name
- NCT00787891
- Testing
- rabeprazole
- Volunteers
- 127 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Inflammatory Bowel Diseases, Colitis, Ulcerative
Initial Experience With a Novel Single-Balloon Enteroscopy System in Children With IBD
To evaluate the safety and efficacy of the NaviAid™ AB in children with known or suspected IBD.
- Conditions
- Inflammatory Bowel Diseases, Colitis, Ulcerative, Crohn Disease
- Trial name
- NCT02629211
- Testing
- NaviAid™ AB
- Where
- Israel
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Smart Medical Systems Ltd.
Veno-occlusive Disease
Study Comparing Efficacy and Safety of Defibrotide vs Best Supportive Care in the Prevention of Hepatic Veno-Occlusive Disease in Adult and Pediatric Patients
This study is to compare the efficacy and safety of defibrotide prophylaxis in addition to best supportive care versus best supportive care alone in the prevention of hepatic veno- occlusive disease (VOD) in adult and pediatric…
- Trial name
- NCT02851407
- Testing
- Defibrotide, Best Supportive Care
- Where
- 114 sites in United States, Australia and 12 more
- Volunteers
- 372 people
- Sponsor
- Jazz Pharmaceuticals
Cystic Fibrosis
A Study to Confirm the Long-term Safety and Effectiveness of Kalydeco in Patients With Cystic Fibrosis Who Have an R117H-CFTR Mutation, Including Pediatric Patients
The purpose of this study is to confirm the long-term safety and effectiveness of Kalydeco® (ivacaftor) in US CF patients with the R117H-CFTR mutation <18 years of age and to describe the long-term safety and effectiveness of…
- Trial name
- NCT02722057
- Volunteers
- 368 people
- Sponsor
- Vertex Pharmaceuticals Incorporated