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

Phase 2

Completed

• Conditions: Hepatitis C
• Interventions: Drug: Peg-Intron; Drug: HCV 796; Drug: REBETOL

• Registration Number: NCT00367887
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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 available

Study Timeline

• Study First Submitted: 2006-08-21
• Study First Submitted QC: 2006-08-21
• Study First Posted: 2006-08-23
• Study Start: 2006-10
• Primary Completion: 2008-07
• Study Completion: 2008-07
• Status Verified: 2013-02
• Disposition First Submitted: 2013-02-07
• Disposition First Submitted QC: 2013-02-07
• Last Update Submitted: 2013-02-07
• Disposition First Posted: 2013-02-11
• Last Update Posted: 2013-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Peg-Intron	-
1	REBETOL	-
2	HCV 796	-
2	Peg-Intron	-
2	REBETOL	-
3	HCV 796	-
3	Peg-Intron	-
3	REBETOL	-

Primary Outcome Measures

Name	Time	Method
Hepatitis C Virus (HCV) RNA concentrations in the blood.	72 weeks

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇵🇷 Santurce, Puerto Rico