Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

Completed · Phase 2

Conditions studied: Hepatitis C

In brief

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.

Key facts

Study ID

NCT00047814

Run by

Astellas Pharma Inc

People needed

48

Starts

2002-10-01

Expected to finish

2006-03-01

Last updated by the study team

2011-12-09

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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