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

NCT00367887 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2013-02-11

No results posted yet for this study

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).

Conditions

  • Hepatitis C

Interventions

DRUG

Peg-Intron

SC injection, weight based dosing, weekly, 48 weeks

DRUG

REBETOL

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

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

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

Sponsors & Collaborators

  • ViroPharma

    collaborator INDUSTRY

  • Wyeth is now a wholly owned subsidiary of Pfizer

    lead INDUSTRY

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-07-31
Completion
2008-07-31

Countries

  • United States
  • Puerto Rico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00367887 on ClinicalTrials.gov