drugset / Trial / NCT00004748
Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
Phase 3
Completed
90 enrolled
National Center for Research Resources (NCRR)
Tufts Medical Center · collab
RandomizedParallel-groupDouble-blindTreatment
Summary
OBJECTIVES: I. Compare the efficacy of low-dose oral pulse methotrexate (MTX) and ursodiol versus colchicine and ursodiol in patients with primary biliary cirrhosis (PBC). II. Determine the optimum dose and duration of MTX treatment. III. Investigate the role of fibrogenic cytokines (FC) in PBC pathogenesis and the effect of treatment on FC production.
Timeline
- Start
- 1989-11
- Primary completion
- —
- Completion
- —
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Colchicine | Small molecule | — | Oral |
| Subject | Methotrexate | Small molecule | — | Oral |
| Background | Ursodeoxycholic Acid | Small molecule | — | Oral |