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Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

Phase 2
Completed
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (9)

Liver Center Huntington Memorial Hospital

πŸ‡ΊπŸ‡Έ

Pasadena, California, United States

Rocky Mount Gastroenterology

πŸ‡ΊπŸ‡Έ

Lakewood, Colorado, United States

University of Florida and Shands Hospital

πŸ‡ΊπŸ‡Έ

Gainsville, Florida, United States

Liver Center BIDMC - Harvard

πŸ‡ΊπŸ‡Έ

Boston, Massachusetts, United States

Gastroenterology and Hepatology

πŸ‡ΊπŸ‡Έ

Kansas City, Missouri, United States

Carolinas Center for Liver Disease

πŸ‡ΊπŸ‡Έ

Charlotte, North Carolina, United States

Duke University

πŸ‡ΊπŸ‡Έ

Durham, North Carolina, United States

Thomas Jefferson University, Gastroenterology and Hepatology

πŸ‡ΊπŸ‡Έ

Philadelphia, Pennsylvania, United States

Northwest Medical Specialties, PLLC Infections Limited, P.S.

πŸ‡ΊπŸ‡Έ

Tacoma, Washington, United States

Liver Center Huntington Memorial Hospital
πŸ‡ΊπŸ‡ΈPasadena, California, United States

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