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

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

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 concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype 1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).

Key facts

Study ID

NCT00367887

Run by

Wyeth is now a wholly owned subsidiary of Pfizer

People needed

246

Starts

2006-10-01

Expected to finish

2008-07-01

Last updated by the study team

2013-02-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Pfizer Investigational Site — Anaheim, California, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — Los Angeles, California, United States
• Pfizer Investigational Site — Pasadena, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Diego, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — San Francisco, California, United States
• Pfizer Investigational Site — Washington D.C., District of Columbia, United States
• Pfizer Investigational Site — Gainesville, Florida, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Atlanta, Georgia, United States
• Pfizer Investigational Site — Louisville, Kentucky, United States
• Pfizer Investigational Site — Boston, Massachusetts, United States
• Pfizer Investigational Site — Worcester, Massachusetts, United States
• Pfizer Investigational Site — Detroit, Michigan, United States
• Pfizer Investigational Site — Plymouth, Minnesota, United States
• Pfizer Investigational Site — Saint Paul, Minnesota, United States
• Pfizer Investigational Site — St Louis, Missouri, United States
• Pfizer Investigational Site — Albuquerque, New Mexico, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — New York, New York, United States
• Pfizer Investigational Site — The Bronx, New York, United States
• Pfizer Investigational Site — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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