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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00367887

Enrollment

246

Registered

2006-08-23

Start date

2006-10-31

Completion date

2008-07-31

Last updated

2013-02-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

Hepatitis C

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).

Interventions

DRUGPeg-Intron

SC injection, weight based dosing, weekly, 48 weeks

DRUGREBETOL

Capsules, weight based dosing, Q12 hrs daily, 48weeks

DRUGHCV 796

Capsules, 500 mg, Q 12 hrs. daily, 48 weeks

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Countries

Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026