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Antiviral Activity and Safety of 3 Different Doses of Mifepristone in Hepatitis C Infected Patients

NCT00255177 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2009-11-03

Study results available
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Summary

Hepatitis C virus (HCV) infects approximately 170 million people worldwide. The current standard- of- care therapy of chronic HCV infection is a regimen of subcutaneously administered (pegylated)-interferon-α and ribavirin for 24 weeks (for genotypes 2 and 3) to 48 weeks (for genotype 1). The sustained viral response rates (SVR) in patients infected with genotypes 2 and 3 are \~80% but remain \<50% in patients infected with genotype 1. The treatment is quite toxic with approximately 30% of patients experiencing adverse events (i.e. depression, fever, anemia, fatigue) requiring dose reduction or discontinuation of therapy. This regimen is contraindicated in women who are pregnant and in patients with decompensated liver disease. The absence of acceptable therapies for many patients with HCV infections makes new therapies desirable for this disease.

Conditions

  • Hepatitis C Virus Infection

Interventions

DRUG

VGX-410 (Mifepristone)

VGX-410 tablets taken daily or twice daily for 28 days

DRUG

Placebo

Placebo for VGX-410 tablets taken daily or twice daily for 28 days

Sponsors & Collaborators

  • VGX Pharmaceuticals, LLC

    lead INDUSTRY

Principal Investigators

  • Bruce Bacon, M.D. · St. Louis University

  • Pablo Tebas, M.D. · University of Pennsylvania

  • George Wu, MD · University of Connecticut

  • Thomas Marbury, MD · Orlando Clinical Research Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2007-09-30
Completion
2008-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT00255177 on ClinicalTrials.gov