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

February 7, 2013 updated by: Wyeth is now a wholly owned subsidiary of Pfizer

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Santurce, Puerto Rico, 00909
        • Pfizer Investigational Site
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92037
        • Pfizer Investigational Site
      • La Jolla, California, United States, 92067
        • Pfizer Investigational Site
      • Los Angeles, California, United States, 90033
        • Pfizer Investigational Site
      • Pasadena, California, United States, 91105
        • Pfizer Investigational Site
      • San Diego, California, United States, 92123
        • Pfizer Investigational Site
      • San Diego, California, United States, 92161
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94115
        • Pfizer Investigational Site
      • San Francisco, California, United States, 94121
        • Pfizer Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Pfizer Investigational Site
    • Florida
      • Gainesville, Florida, United States, 32610
        • Pfizer Investigational Site
      • Miami, Florida, United States, 33136
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Pfizer Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Pfizer Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Pfizer Investigational Site
      • Worcester, Massachusetts, United States, 01655
        • Pfizer Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Pfizer Investigational Site
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Pfizer Investigational Site
      • St. Paul, Minnesota, United States, 55117
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, United States, 63104
        • Pfizer Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Pfizer Investigational Site
    • New York
      • Bronx, New York, United States, 10461
        • Pfizer Investigational Site
      • Bronx, New York, United States, 10468
        • Pfizer Investigational Site
      • New York, New York, United States, 10021
        • Pfizer Investigational Site
      • New York, New York, United States, 10032
        • Pfizer Investigational Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7209
        • Pfizer Investigational Site
      • Durham, North Carolina, United States, 27710
        • Pfizer Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Pfizer Investigational Site
      • Cleveland, Ohio, United States, 44195
        • Pfizer Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Pfizer Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Pfizer Investigational Site
    • Virginia
      • Annandale, Virginia, United States, 22003
        • Pfizer Investigational Site
      • Fairfax, Virginia, United States, 22031
        • Pfizer Investigational Site
      • Richmond, Virginia, United States, 23249
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 1
Drug: Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
Drug: REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
ACTIVE_COMPARATOR: 2
Drug: Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
Drug: REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
Drug: HCV 796
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
ACTIVE_COMPARATOR: 3
Drug: Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
Drug: REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
Drug: HCV 796
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Hepatitis C Virus (HCV) RNA concentrations in the blood.
Time Frame: 72 weeks
72 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Collaborators

ViroPharma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (ACTUAL)

July 1, 2008

Study Completion (ACTUAL)

July 1, 2008

Study Registration Dates

First Submitted

August 21, 2006

First Submitted That Met QC Criteria

August 21, 2006

First Posted (ESTIMATE)

August 23, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2013

Last Update Submitted That Met QC Criteria

February 7, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3173A1-200
  • B3381001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatitis C

Clinical Trials on Peg-Intron

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe