drugset / Trial / NCT00004784
Phase III Randomized Study of Ursodiol With Vs Without Methotrexate for Primary Biliary Cirrhosis
Phase 3
Completed
315 enrolled
National Center for Research Resources (NCRR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collabUniversity of Texas · collab
RandomizedDouble-blindTreatment
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.
Timeline
- Start
- 1994-01
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Methotrexate | Small molecule | — | — |
| Background | Ursodeoxycholic Acid | Small molecule | — | — |