Overview

Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National Center for Research Resources (NCRR)
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Texas
Treatments:
Methotrexate
Ursodeoxycholic Acid
Criteria
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- The following criteria must be met prior to study entry and
ursodiol treatment: Bilirubin less than 3 mg/dL Alkaline phosphatase at least 1.5 times
normal limits Albumin at least 3 g/dL The following criteria must be met prior to
randomization to Arms I and II: Primary biliary cirrhosis (PBC), i.e.: Cholestatic liver
disease for at least 6 months prior to randomization Liver biopsy compatible with PBC
within 6 months prior to randomization No biliary obstruction on ultrasound, computerized
tomography, or cholangiography The following exclude: Asymptomatic and stage I liver
histology (Ludwig classification) Hepatic encephalopathy Ascites Variceal bleeding No liver
disease of other etiology, e.g.: Chronic hepatitis B or C Autoimmune chronic active
hepatitis Alcoholic liver disease Sclerosing cholangitis Drug-induced liver disease
Symptomatic or obstructive gallstones --Prior/Concurrent Therapy-- At least 6 months since
the following immunosuppressives: Cyclosporine Tacrolimus Methotrexate At least 3 months
since other immunosuppressives, e.g.: Azathioprine Chlorambucil Colchicine Corticosteroids
Penicillamine At least 3 months since rifampin --Patient Characteristics-- Life expectancy:
No major illness limiting life span Hematopoietic: WBC at least 2500/mm3 Absolute
granulocyte count at least 1500/mm3 Platelet count at least 80,000/mm3 Hepatic: See Disease
Characteristics Renal: Creatinine clearance at least 60 mL/min Pulmonary: No diffusion
capacity or vital capacity less than 50% of predicted Other: Antimitochondrial antibody
positive HIV antibody negative No alcoholism within the past 2 years No epilepsy requiring
phenytoin No malignancy within the past 5 years other than skin cancer No pregnant women
Adequate contraception required of fertile patients