Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

This study has been completed.

First Received: October 18, 2002 Last Updated: July 28, 2008 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborator:	Astellas Pharma US, Inc.
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00047814

Purpose

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.

Condition	Intervention	Phase
Hepatitis C	Drug: FK788	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: FK 788

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment:	48
Study Start Date:	October 2002

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00047814

Locations

United States, California
Liver Center Huntington Memorial Hospital
Pasadena, California, United States, 91105
United States, Colorado
Rocky Mount Gastroenterology
Lakewood, Colorado, United States, 80215
United States, Florida
University of Florida and Shands Hospital
Gainsville, Florida, United States, 32610
United States, Massachusetts
Liver Center BIDMC - Harvard
Boston, Massachusetts, United States, 02215
United States, Missouri
Gastroenterology and Hepatology
Kansas City, Missouri, United States, 64131
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27705
Carolinas Center for Liver Disease
Charlotte, North Carolina, United States, 28203
United States, Pennsylvania
Thomas Jefferson University, Gastroenterology and Hepatology
Philadelphia, Pennsylvania, United States, 19107
United States, Washington
Northwest Medical Specialties, PLLC Infections Limited, P.S.
Tacoma, Washington, United States, 98405

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma US, Inc.

More Information

No publications provided

Study ID Numbers:	FA-788-0004
Study First Received:	October 18, 2002
Last Updated:	July 28, 2008
ClinicalTrials.gov Identifier:	NCT00047814 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

HCV

Additional relevant MeSH terms:

Virus Diseases
Hepatitis
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Flaviviridae Infections

Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Infection
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 27, 2009