Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
- Conditions
- Hepatitis C
- Registration Number
- NCT00047814
- Lead Sponsor
- Astellas Pharma Inc
- Brief Summary
The purpose of this study is to assess the safety, tolerability and pharmacokinetics of 4 weeks therapy with FK788 in subjects with chronic hepatitis C virus (HCV) infection. Also, to assess the effect of FK788 on serum ALT concentration and hepatitis C viral level during therapy and for four weeks following therapy.
- Detailed Description
This is a multi-center, randomized, investigator and subject blinded, placebo-controlled eight week study, including a four week treatment period and a four week follow-up period. Three cohorts of HCV positive subjects will be studied in a sequential manner.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 48
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (9)
Liver Center Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
Rocky Mount Gastroenterology
🇺🇸Lakewood, Colorado, United States
University of Florida and Shands Hospital
🇺🇸Gainsville, Florida, United States
Liver Center BIDMC - Harvard
🇺🇸Boston, Massachusetts, United States
Gastroenterology and Hepatology
🇺🇸Kansas City, Missouri, United States
Carolinas Center for Liver Disease
🇺🇸Charlotte, North Carolina, United States
Duke University
🇺🇸Durham, North Carolina, United States
Thomas Jefferson University, Gastroenterology and Hepatology
🇺🇸Philadelphia, Pennsylvania, United States
Northwest Medical Specialties, PLLC Infections Limited, P.S.
🇺🇸Tacoma, Washington, United States
Liver Center Huntington Memorial Hospital🇺🇸Pasadena, California, United States