Houston, Texas 77030

  • Biliary Atresia

Purpose:

The purpose of this study is to determine whether pentoxifylline reduces liver damage in infants with biliary atresia.


Study summary:

Biliary atresia (BA) is a devastating liver disease of infancy of unknown etiology, characterized by bile duct obstruction, live fibrosis, and cirrhosis. BA has no known medical treatments. The only proven treatment is a surgical portoenterostomy (the Kasai procedure, or KP) which can achieve bile drainage and improve outcomes in some cases. The KPs success is variable depending on several factors including age of the infant, experience of the surgeon, and extent of liver fibrosis at the time of KP. In this study, the investigators conduct a phase II trial of a potential new medical therapy for BA: pentoxifylline (PTX). PTX is a methylxanthine derivative closely related to caffeine that has been used safely in infants with other diseases such as sepsis. In adults, PTX has been shown to have a number of properties beneficial to the liver, including preventing liver fibrosis, improving liver regeneration, and reducing cirrhosis-related complications. The trial's objective is to determine whether PTX has sufficient biological activity against BA to warrant further study. PTX will be administered orally for 90 days as an adjunct to standard therapy (i.e. KP if appropriate). The primary outcome will measure the change in serum conjugated bilirubin levels after 90 days. Secondary outcomes include changes in body weight, serum markers, liver imaging, and time to liver transplant in infants with BA.


Criteria:

Inclusion Criteria: - 0-180 days old - Diagnosed with biliary atresia through liver biopsy and/or intra-operative cholangiogram - No previous Kasai portoenterostomy performed at another institution - Able to take medications orally - Legal guardian signs consent after understanding risks and investigational nature of study Exclusion Criteria: - Infants greater than 180 days old - Infants receiving a Kasai portoenterostomy at another institution - Infants unable to take medications orally


NCT ID:

NCT01774487


Primary Contact:

Principal Investigator
Sanjiv Harpavat, MD PhD
Baylor College of Medicine

Sanjiv Harpavat, MD PhD
Phone: 832-824-2099 ext. 2144
Email: harpavat@bcm.edu


Backup Contact:

Email: Ross.Shepherd@bcm.edu
Ross Shepherd, MD
Phone: 832-824-2099 ext. 1223


Location Contact:

Houston, Texas 77030
United States

Sanjiv Harpavat, MD PhD
Phone: 832-824-2099
Email: harpavat@bcm.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 17, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

If you would like to be contacted by the clinical trial representative please fill out the form below.