Status:

COMPLETED

A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects

Lead Sponsor:

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborating Sponsors:

ViroPharma

Conditions:

Hepatitis C

Eligibility:

All Genders

18-65 years

Phase:

PHASE2

Brief Summary

This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus conco...

Eligibility Criteria

Inclusion

  • Infection with HCV genotype 1.
  • HCV- infected subjects naive to treatment.
  • HCV-infected non-responder subjects.

Exclusion

  • Women who are pregnant or breastfeeding.
  • ALT \>/ or = 5X the upper limit of normal.
  • AST \>/ or = 5X the upper limit of normal.

Key Trial Info

Start Date :

October 1 2006

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

July 1 2008

Estimated Enrollment :

246 Patients enrolled

Trial Details

Trial ID

NCT00367887

Start Date

October 1 2006

End Date

July 1 2008

Last Update

February 11 2013

Active Locations (35)

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Page 1 of 9 (35 locations)

1

Pfizer Investigational Site

Anaheim, California, United States, 92801

2

Pfizer Investigational Site

La Jolla, California, United States, 92037

3

Pfizer Investigational Site

La Jolla, California, United States, 92067

4

Pfizer Investigational Site

Los Angeles, California, United States, 90033