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

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vertex Pharmaceuticals Incorporated
• Collaborator: ViroChem Pharma
• Treatments: Interferon-alpha; Peginterferon alfa-2a; Ribavirin

Criteria

Inclusion Criteria:

• Male and Female subjects, 18-65 years of age (females non-child bearing potential in Part B)

• Have laboratory evidence of HCV infection for 6 months, defined by (1) presence of anti-HCV antibody (Genotype 1a and 1b infection), or (2)documented HCV RNA presence by a sensitive and specific assay and (3 histologic evidence of CHC (Fibrosis on a standardized histological grading system)

• Plasma HCV RNA of 100,000 IU/ml

• HIV 1 and HIV2 ab seronegative

• Body Mass Index (BMI) ≤ 35 kg/m2 BMI

• Treatment Naive subjects

Exclusion Criteria:

• Contraindications to peginterferon or ribavirin therapy

• Have evidence of liver cirrhosis, decompensated liver disease, and Child-Pugh score > 5

• Have hemoglobinopathies, unstable cardiac disease, history of organ transplant, active malignant disease or uncontrolled Type I or II diabetes