Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection - Tabular View

Tracking Information
First Received Date ^ICMJE	October 18, 2002
Last Updated Date	July 28, 2008
Start Date ^ICMJE	October 2002
Primary Completion Date
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00047814 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
Official Title ^ICMJE	A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Condition ^ICMJE	Hepatitis C
Intervention ^ICMJE	Drug: FK788
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	48
Completion Date
Primary Completion Date
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years to 60 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00047814
Responsible Party
Study ID Numbers ^ICMJE	FA-788-0004
Study Sponsor ^ICMJE	Astellas Pharma Inc
Collaborators ^ICMJE	Astellas Pharma US, Inc.
Investigators ^ICMJE
Information Provided By	Astellas Pharma Inc
Verification Date	March 2006
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP