NCT00367887

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 246 (actual)
• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2006-10-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2006-08-23
• Last updated: 2013-02-11

Locations

35 sites across 2 countries: United States, Puerto Rico