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

Vertex Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hepatitis C

Treatments: Drug: ribavirin; Drug: VCH-222 or matching placebo; Biological: peginterferon alfa-2a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00911963

VCH-222-102

Details and patient eligibility

About

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.

Enrollment: 49 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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49 participants in 2 patient groups

Part A

Experimental group

Description:

This will be a 4 dose escalation study comparing VCH-222 to placebo treatment.

Treatment:

Drug: VCH-222 or matching placebo

Drug: VCH-222 or matching placebo

Part B

Experimental group

Description:

VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks

Treatment:

Drug: ribavirin

Biological: peginterferon alfa-2a

Drug: VCH-222 or matching placebo

Drug: VCH-222 or matching placebo