Status:
COMPLETED
A Randomized, Double-Blinded, Placebo-Controlled Trial of Corticosteroid Therapy Following Portoenterostomy
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Biliary Atresia
Eligibility:
All Genders
Up to 6 years
Phase:
NA
Brief Summary
The Children Liver Disease Research and Education Network (ChiLDREN) is conducting a clinical trial to evaluate whether long-term treatment with corticosteroids improves the outcome of the Kasai or ga...
Detailed Description
This is a multi-center randomized, double-blinded, placebo-controlled trial to prospectively determine the efficacy of corticosteroids on the outcome of infants with biliary atresia. The trial will be...
Eligibility Criteria
Inclusion
- Portoenterostomy or gall bladder Kasai operation for biliary atresia within the previous 72 hours
- Post-conception age ≥ 36 weeks
- Weight at enrolment ≥ 2000 gm
- Written informed consent to participate in the study obtained prior to or within 72 hours of completion of portoenterostomy. (Note: Families of potential subjects may be approached prior to the portoenterostomy.)
Exclusion
- Known immunodeficiency
- Diabetes mellitus
- Presence of significant systemic hypertension for age (persistent systolic blood pressure ≥112 mmHg)
- A serum indirect (unconjugated) bilirubin ≥ 5 mg/dL for infants under 4 weeks of age or ≥ 7 mg/dL for infants between 4 and 8 weeks of age
- Known sensitivity to corticosteroids
- Documented bacteremia or other tissue infection which is felt to be clinically relevant
- Known congenital infection or disease with herpes simplex virus, toxoplasmosis, or cytomegalovirus inclusion disease of the liver
- Infants whose mother is known to have human immunodeficiency virus infection
- Infants whose mother is known to be HBsAg or hepatitis C virus positive
- Infants with other severe concurrent illnesses such as neurological, cardiovascular, pulmonary, metabolic, endocrine, and renal disorders that would interfere with the conduct and results of the study
- Any other clinical condition that is a contraindication to the use of corticosteroid (e.g., bowel perforation)
- Infants who have received the live attenuated rotavirus vaccine (e.g., Rotateq) within 5 days prior to proposed administration of study drug
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT00294684
Start Date
November 1 2005
End Date
January 1 2013
Last Update
October 22 2019
Active Locations (14)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
University of California at San Francisco
San Francisco, California, United States, 94143
3
The Children's Hospital
Aurora, Colorado, United States, 80045
4
Children's Hospital of Atlanta - Emory University
Atlanta, Georgia, United States, 30322