Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

December 8, 2011 updated by: Astellas Pharma Inc

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

48

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2002

Study Completion (Actual)

March 1, 2006

Study Registration Dates

First Submitted

October 18, 2002

First Submitted That Met QC Criteria

October 23, 2002

First Posted (Estimate)

October 24, 2002

Study Record Updates

Last Update Posted (Estimate)

December 9, 2011

Last Update Submitted That Met QC Criteria

December 8, 2011

Last Verified

December 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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