Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004748
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
Phase III Randomized Double-Blind Placebo-Controlled Study of Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
Status:
COMPLETED
Status Verified Date:
2001-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 priorconcurrent 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
This is a randomized double-blind study Patients are stratified by priorconcurrent 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
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NEMCH-454 | None | None | None |