Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

• Status: Completed
• Trial end date: 2006-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Collaborator: Astellas Pharma US, Inc.

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