Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis
Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
OBJECTIVES: I. Compare the effects of ursodiol (ursodeoxycholic acid), with and without
methotrexate, on pruritus, incapacitation index, and serum markers of activity and severity
in patients with primary biliary cirrhosis.
II. Compare the effects of these regimens on the development of ascites, encephalopathy,
varices (or bleeding from pre-existing varices), histologic liver changes, transplantation,
and survival.
III. Compare the toxicity and safety of each regimen.
Phase:
Phase 3
Details
Lead Sponsor:
National Center for Research Resources (NCRR)
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Texas