NCT00911963

Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection

A Phase l b/II a, Multicenter, Randomized, Double-Blinded, and Placebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C-Infection

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess antiviral activity when administered alone for 3 days or in combination with peginterferon and ribavirin for 12 weeks. This study will also evaluate the safety and tolerability of treatment with VCH-222 when given alone or in combination with peginterferon and ribavirin. The study will also evaluate the pharmacokinetic profile of VCH-222 in HCV infected subjects.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DRUG	VCH-222 or matching placebo	capsule, oral, 4 doses once daily or twice daily, 3 days
DRUG	VCH-222 or matching placebo	capsule, oral, 400 mg twice daily or 750 mg twice daily, 12 weeks
BIOLOGICAL	peginterferon alfa-2a	subcutaneous injection, 180 μg, once weekly, 48 weeks
DRUG	ribavirin	tablet, oral, 1000-1200 mg daily based on body weight, 48 weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-09-01
• Completion: 2012-09-01
• First posted: 2009-06-03
• Last updated: 2014-03-10

Locations

10 sites across 4 countries: United States, Argentina, Canada, Puerto Rico