Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

colchicine

methotrexate

ursodiol

About this trial

This is an interventional treatment trial for Liver Cirrhosis, Biliary focused on measuring cirrhosis, gastrointestinal disorders, primary biliary cirrhosis, rare disease

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Biopsy proven primary biliary cirrhosis (PBC); Disproportionate increase in alkaline phosphatase; Positive antimitochondrial antibody test OR Symptoms consistent with PBC, e.g.: pruritus, fatigue, malaise, jaundice, elevated bilirubin No clinically advanced PBC, i.e.: bilirubin greater than 10 mg/dL or albumin less than 2.5 g/dL, determined by 2 analyses 10 weeks apart; bleeding esophageal varices or congestive gastropathy; chronic hepatic encephalopathy; chronic ascites --Prior/Concurrent Therapy-- No concurrent drugs associated with chronic liver disease --Patient Characteristics-- Hematopoietic: WBC at least 2500 Platelets at least 100,000 (unless due to hypersplenism); Hematocrit at least 30% Renal: No renal disease that could cause liver dysfunction Other: No history of alcohol abuse; No other medical illness that might cause liver dysfunction, e.g., severe cardiac failure; No pregnant women

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00004748

First Posted

February 24, 2000

Last Updated

June 23, 2005

Sponsor

National Center for Research Resources (NCRR)

Collaborators

Tufts Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00004748

Brief Title

Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis

Official Title

Phase III Randomized, Double-Blind, Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis

Study Type

Interventional

2. Study Status

Record Verification Date

December 2001

Overall Recruitment Status

Completed

Study Start Date

November 1989 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

Tufts Medical Center

4. Oversight

5. Study Description

Brief 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.

Detailed Description

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by prior/concurrent medical management. Patients in the first group are treated with oral methotrexate 3 times a week and a daily oral placebo. Patients in the second group are treated with daily oral colchicine and an oral placebo 3 times a week. Therapy continues for 10 years. Beginning year 2, daily oral ursodiol is administered to all patients. Patients with disease progression are crossed to the alternate group or undergo liver transplantation if clinically indicated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Liver Cirrhosis, Biliary

Keywords

cirrhosis, gastrointestinal disorders, primary biliary cirrhosis, rare disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

90 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

colchicine

Intervention Type

Drug

Intervention Name(s)

methotrexate

Intervention Type

Drug

Intervention Name(s)

ursodiol

10. Eligibility

Sex

All

Minimum Age & Unit of Time

0 Years

Accepts Healthy Volunteers

No

Eligibility Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Biopsy proven primary biliary cirrhosis (PBC); Disproportionate increase in alkaline phosphatase; Positive antimitochondrial antibody test OR Symptoms consistent with PBC, e.g.: pruritus, fatigue, malaise, jaundice, elevated bilirubin No clinically advanced PBC, i.e.: bilirubin greater than 10 mg/dL or albumin less than 2.5 g/dL, determined by 2 analyses 10 weeks apart; bleeding esophageal varices or congestive gastropathy; chronic hepatic encephalopathy; chronic ascites --Prior/Concurrent Therapy-- No concurrent drugs associated with chronic liver disease --Patient Characteristics-- Hematopoietic: WBC at least 2500 Platelets at least 100,000 (unless due to hypersplenism); Hematocrit at least 30% Renal: No renal disease that could cause liver dysfunction Other: No history of alcohol abuse; No other medical illness that might cause liver dysfunction, e.g., severe cardiac failure; No pregnant women

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marshall M. Kaplan

Organizational Affiliation

Tufts Medical Center

Official's Role

Study Chair

Liver Cirrhosis, Biliary

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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