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Study of Long-term Peg Intron vs. Colchicine in Non-responders.

NCT00179413 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 549

Last updated 2017-07-11

Study results available
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Summary

In this study Peg-Intron will be tested to see if it will give better results than Colchicine. At this time, there is currently no recommended maintenance treatment for patients who have failed to respond to Interferon/Rebetron/Peg Intron and have advanced fibrosis. The purpose of this study is to compare two treatments to slow down the progression of liver disease and to prevent liver failure and liver cancer. The treatment will not cure Hepatitis C, but is being evaluated to see if it can slow down disease progression.

Conditions

  • Hepatitis C Virus
  • Advanced Fibrosis
  • Cirrhosis

Interventions

DRUG

PEG -Intron

DRUG

Colchicine

0.6mg twice a day

Sponsors & Collaborators

Principal Investigators

  • Nezam H Afdhal, MD · Beth Israel Deaconess Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-15
Primary Completion
2009-12-31
Completion
2010-03-03

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00179413 on ClinicalTrials.gov