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NCT00367887 Clinical Trial

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

Hepatitis C Clinical Trial

Official title:
A Phase 2, Randomized, Open-Label Study Of The Safety, Antiviral Activity, And Pharmacokinetics Of HCV-796 Administered In Combination With Peginterferon Alfa 2B (Peg-Intron) Plus Ribavirin (Rebetol) Versus Peg-Intron Plus Rebetol In Subjects With Hepatitis C Virus Genotype 1 Infection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00367887
Other study ID # 3173A1-200
Secondary ID B3381001
Status Completed
Phase Phase 2
First received August 21, 2006
Last updated February 7, 2013
Start date October 2006
Est. completion date July 2008

Study information
Verified date February 2013
Source Wyeth is now a wholly owned subsidiary of Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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 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).

Recruitment information / eligibility
Status Completed
Enrollment 246
Est. completion date July 2008
Est. primary completion date July 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Infection with HCV genotype 1.

- HCV- infected subjects naive to treatment.

- HCV-infected non-responder subjects.

Exclusion Criteria:

- Women who are pregnant or breastfeeding.

- ALT >/ or = 5X the upper limit of normal.

- AST >/ or = 5X the upper limit of normal.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
• REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
• HCV 796
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
• Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
• REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
• HCV 796
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
• Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
• REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks

Locations
Country Name City State
Puerto Rico Pfizer Investigational Site Santurce
United States Pfizer Investigational Site Albuquerque New Mexico
United States Pfizer Investigational Site Anaheim California
United States Pfizer Investigational Site Annandale Virginia
United States Pfizer Investigational Site Atlanta Georgia
United States Pfizer Investigational Site Boston Massachusetts
United States Pfizer Investigational Site Bronx New York
United States Pfizer Investigational Site Bronx New York
United States Pfizer Investigational Site Chapel Hill North Carolina
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cleveland Ohio
United States Pfizer Investigational Site Detroit Michigan
United States Pfizer Investigational Site Durham North Carolina
United States Pfizer Investigational Site Fairfax Virginia
United States Pfizer Investigational Site Gainesville Florida
United States Pfizer Investigational Site Houston Texas
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 Louisville Kentucky
United States Pfizer Investigational Site Miami Florida
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site New York New York
United States Pfizer Investigational Site Pasadena California
United States Pfizer Investigational Site Philadelphia Pennsylvania
United States Pfizer Investigational Site Plymouth Minnesota
United States Pfizer Investigational Site Richmond Virginia
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 St. Louis Missouri
United States Pfizer Investigational Site St. Paul Minnesota
United States Pfizer Investigational Site Washington District of Columbia
United States Pfizer Investigational Site Worcester Massachusetts

Sponsors (2)
Lead Sponsor Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer ViroPharma

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hepatitis C Virus (HCV) RNA concentrations in the blood. 72 weeks No
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