Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection
- Conditions
- Hepatitis C
- Interventions
- Registration Number
- NCT00911963
- Lead Sponsor
- Vertex Pharmaceuticals Incorporated
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Part A VCH-222 or matching placebo This will be a 4 dose escalation study comparing VCH-222 to placebo treatment. Part B VCH-222 or matching placebo VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks Part B peginterferon alfa-2a VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks Part B ribavirin VCH-222 + peginterferon alfa-2a + ribavirin (12 weeks) followed by peginterferon alfa-2a + ribavirin for 36 weeks
- Primary Outcome Measures
Name Time Method To assess the antiviral activity of VCH-222, in subjects with genotype 1 hepatitis C virus (HCV) infection after once (QD) or twice (b.i.d.) daily dosing for 3 days (Part A) Daily for the first 3 days and at each study visit To assess the antiviral activity of VCH-222, in subjects with genotype 1 HCV infection after b.i.d. daily dosing for 12 weeks in combination with Peg-interferon-alfa-2a and ribavirin (Part B) Week 4 and Week 12 Assess the safety and tolerability of VCH-222 when administered in combination with Peg-IFN-alfa-2a/RBV for 12 weeks (Part B) Study visits throughout part B
- Secondary Outcome Measures
Name Time Method To assess the safety and tolerability of VCH-222 when administered for 3 days in monotherapy (Part A) Study visits throughout Part A To evaluate the pharmacokinetic (PK) profile of VCH-222 in HCV infected subjects (Part B) Time points through Part B
Trial Locations
- Locations (10)
Alamo Medical Research
🇺🇸San Antonio, Texas, United States
Downtown ID Clinic/University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Ottawa Hospital
🇨🇦Ottawa, Ontario, Canada
Gastrointestinal Specialists of Georgia PC
🇺🇸Marietta, Georgia, United States
John Buhler Research Centre
🇨🇦Winnipeg, Manitoba, Canada
ACLIRES Argentina SRL
🇦🇷Buenos Aires, Argentina
Fundacion de Investigation de Diego
🇵🇷Santurce, Puerto Rico
Henry Ford Health Sytem
🇺🇸Detroit, Michigan, United States
Hospital Universitario Austral
🇦🇷Buenos Aires, Argentina
The liver institute at Methodist hospital
🇺🇸Dallas, Texas, United States