Status:
COMPLETED
Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection
Lead Sponsor:
Vertex Pharmaceuticals Incorporated
Collaborating Sponsors:
ViroChem Pharma
Conditions:
Hepatitis C
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00911963
Start Date
April 1 2009
End Date
September 1 2012
Last Update
March 10 2014
Active Locations (10)
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1
Gastrointestinal Specialists of Georgia PC
Marietta, Georgia, United States, 30060
2
Henry Ford Health Sytem
Detroit, Michigan, United States, 48202
3
The liver institute at Methodist hospital
Dallas, Texas, United States, 75203
4
Alamo Medical Research
San Antonio, Texas, United States, 78215