Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

This study has been completed.
Sponsor:
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00047814
First received: October 18, 2002
Last updated: December 8, 2011
Last verified: December 2011
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Estimated Enrollment: 48
Study Start Date: October 2002
Study Completion Date: March 2006
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Carolinas Center for Liver Disease
Charlotte, North Carolina, United States, 28203
Duke University
Durham, North Carolina, United States, 27705
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

ClinicalTrials.gov Identifier: NCT00047814     History of Changes
Other Study ID Numbers: FA-788-0004
Study First Received: October 18, 2002
Last Updated: December 8, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on September 18, 2014