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
πΊπΈPasadena, California, United States
Rocky Mount Gastroenterology
πΊπΈLakewood, Colorado, United States
University of Florida and Shands Hospital
πΊπΈGainsville, Florida, United States
Liver Center BIDMC - Harvard
πΊπΈBoston, Massachusetts, United States
Gastroenterology and Hepatology
πΊπΈKansas City, Missouri, United States
Carolinas Center for Liver Disease
πΊπΈCharlotte, North Carolina, United States
Duke University
πΊπΈDurham, North Carolina, United States
Thomas Jefferson University, Gastroenterology and Hepatology
πΊπΈPhiladelphia, Pennsylvania, United States
Northwest Medical Specialties, PLLC Infections Limited, P.S.
πΊπΈTacoma, Washington, United States
Liver Center Huntington Memorial HospitalπΊπΈPasadena, California, United States