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

This study has been completed.
Sponsor:
Collaborator:
ViroPharma
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00367887
First received: August 21, 2006
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Hepatitis C
Drug: Peg-Intron
Drug: REBETOL
Drug: HCV 796
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • Hepatitis C Virus (HCV) RNA concentrations in the blood. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]

Enrollment: 246
Study Start Date: October 2006
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: HCV 796
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
Drug: Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
Drug: REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks
Active Comparator: 3 Drug: HCV 796
Capsules, 500 mg, Q 12 hrs. daily, 48 weeks
Drug: Peg-Intron
SC injection, weight based dosing, weekly, 48 weeks
Drug: REBETOL
Capsules, weight based dosing, Q12 hrs daily, 48weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367887

  Show 35 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
ViroPharma
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00367887     History of Changes
Other Study ID Numbers: 3173A1-200, B3381001
Study First Received: August 21, 2006
Last Updated: February 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Hepatitis C

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Digestive System Diseases
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
RNA Virus Infections
Virus Diseases
Interferon-alpha
Peginterferon alfa-2b
Ribavirin
Anti-Infective Agents
Antimetabolites
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2015