Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

Astellas

Status and phase

Completed

Phase 2

Conditions

Hepatitis C

Treatments

Drug: FK788

Study type

Interventional

Funder types

Industry

Identifiers

NCT00047814

FA-788-0004

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

The following criteria is a brief summary of Criterion required for trial participation.

Inclusion Criteria

Has chronic hepatitis C virus infection and has previously received at least three months of treatment with any approved therapy and failed to respond, relapsed or did not tolerate therapy
Has positive HCV RNA by RT-PCR
Has abnormal ALT levels (at least 2 X ULN)
Has liver biopsy within past 2 years consistent with chronic hepatitis, no evidence of non-alcoholic steatohepatitis or cirrhosis, and at least mild inflammation
Has normal liver function indicated by: PT =< 2 sec. prolonged compared to the ULN, Albumin >= 3.5 g/dL, Total bilirubin =< 1.5 mg/dL
ANA titer =< 1:160

Exclusion Criteria

Has positive skin test for tuberculosis
Has ALT value >= 300 IU/L
Has abnormal hematological parameters indicated by: ANC < 1500/mm3 and Platelets < 100,000/mm3
Has creatinine > 1.5 X ULN
AFP > 50 ng/mL and evidence of hepatocellular carcinoma on ultrasound
Is a carrier of the hepatitis B surface antigen (HBsAg), positive for HIV-1 and/or HIV-2 antibodies