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).
- Infection with HCV genotype 1.
- HCV- infected subjects naive to treatment.
- HCV-infected non-responder subjects.
- Women who are pregnant or breastfeeding.
- ALT >/ or = 5X the upper limit of normal.
- AST >/ or = 5X the upper limit of normal.
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects | |||
| Official Title ICMJE | 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 | |||
| 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 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). | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 2 | |||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
| Condition ICMJE | Hepatitis C | |||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | |||
| * Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 246 | |||
| Original Enrollment ICMJE | 267 | |||
| Actual Study Completion Date ICMJE | July 2008 | |||
| Actual Primary Completion Date | July 2008 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 65 Years (Adult, Older Adult) | |||
| Accepts Healthy Volunteers ICMJE | No | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Puerto Rico, United States | |||
| Removed Location Countries | United Kingdom | |||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00367887 | |||
| Other Study ID Numbers ICMJE | 3173A1-200 B3381001 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | ViroPharma | |||
| Investigators ICMJE |
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| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | February 2013 | |||
| ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
