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Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

Primary Purpose

Hepatitis C

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
FK788
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring HCV

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Liver Center Huntington Memorial Hospital
  • Rocky Mount Gastroenterology
  • University of Florida and Shands Hospital
  • Liver Center BIDMC - Harvard
  • Gastroenterology and Hepatology
  • Carolinas Center for Liver Disease
  • Duke University
  • Thomas Jefferson University, Gastroenterology and Hepatology
  • Northwest Medical Specialties, PLLC Infections Limited, P.S.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 18, 2002
Last Updated
December 8, 2011
Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00047814
Brief Title
Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
Official Title
A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Astellas Pharma Inc
Collaborators
Astellas Pharma US, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
HCV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
48 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
FK788

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Liver Center Huntington Memorial Hospital
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Rocky Mount Gastroenterology
City
Lakewood
State/Province
Colorado
ZIP/Postal Code
80215
Country
United States
Facility Name
University of Florida and Shands Hospital
City
Gainsville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Liver Center BIDMC - Harvard
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Gastroenterology and Hepatology
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Carolinas Center for Liver Disease
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States
Facility Name
Thomas Jefferson University, Gastroenterology and Hepatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Northwest Medical Specialties, PLLC Infections Limited, P.S.
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States

12. IPD Sharing Statement

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Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

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