Antifibrotic Activity Of GI262570 In Chronic Hepatitis C Subjects

NCT00244751 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2017-12-11

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who are enrolled in the study must have had prior treatment with interferon (either pegylated or standard interferon) plus ribavirin for at least 12 weeks to treat their hepatitis C, but either failed to clear the virus or didn't tolerate the treatment.

Conditions

  • Cirrhosis, Liver

Interventions

DRUG

GI262570 0.5 mg

GI262570 0.5 mg

DRUG

GI262570 1.0 mg

GI262570 1.0 mg

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • GSK Clinical Trials · GlaxoSmithKline

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-02
Primary Completion
2008-03-13
Completion
2008-03-13

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Germany
  • Israel
  • Malaysia
  • New Zealand
  • Puerto Rico
  • Romania
  • Russia
  • Singapore
  • South Korea
  • Taiwan

Study Locations

More Related Trials

Entities

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 NCT00244751 on ClinicalTrials.gov