Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00047814
Recruitment Status : Completed
First Posted : October 24, 2002
Last Update Posted : December 9, 2011
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc

October 18, 2002
October 24, 2002
December 9, 2011
October 2002
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Complete list of historical versions of study NCT00047814 on Archive Site
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Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Hepatitis C
Drug: FK788
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2006
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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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Astellas Pharma Inc
Astellas Pharma US, Inc.
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Astellas Pharma Inc
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP