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

Wyeth

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Drug: HCV 796; Drug: Peg-Intron; Drug: REBETOL

Study type: Interventional

Funder types: Industry

Identifiers

NCT00367887

B3381001

3173A1-200

Details and patient eligibility

About

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).

Enrollment: 246 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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246 participants in 3 patient groups

1

Active Comparator group

Treatment:

Drug: Peg-Intron

Drug: REBETOL

Drug: Peg-Intron

Drug: REBETOL

Drug: REBETOL

Drug: Peg-Intron

2

Active Comparator group

Treatment:

Drug: Peg-Intron

Drug: REBETOL

Drug: HCV 796

Drug: Peg-Intron

Drug: REBETOL

Drug: HCV 796

Drug: REBETOL

Drug: Peg-Intron

3

Active Comparator group

Treatment:

Drug: Peg-Intron

Drug: REBETOL

Drug: HCV 796

Drug: Peg-Intron

Drug: REBETOL

Drug: HCV 796

Drug: REBETOL

Drug: Peg-Intron