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Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

This study has been completed.

Sponsors and Collaborators: Astellas Pharma Inc
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

MedlinePlus related topics:   Hepatitis    Hepatitis C   

ChemIDplus related topics:   FK 788   

U.S. FDA Resources

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

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


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

Keywords provided by Astellas Pharma Inc:
HCV  

Study placed in the following topic categories:
Virus Diseases
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Hepatitis, Viral, Human
Hepatitis C
Hepatitis C, Chronic

Additional relevant MeSH terms:
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on October 10, 2008




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