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Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

NCT ID: NCT00047814

Last Updated: 2011-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-03-31

Brief Summary

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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

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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.

Conditions

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Hepatitis C

Keywords

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HCV

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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FK788

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma US, Inc.

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Locations

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Liver Center Huntington Memorial Hospital

Pasadena, California, United States

Site Status

Rocky Mount Gastroenterology

Lakewood, Colorado, United States

Site Status

University of Florida and Shands Hospital

Gainsville, Florida, United States

Site Status

Liver Center BIDMC - Harvard

Boston, Massachusetts, United States

Site Status

Gastroenterology and Hepatology

Kansas City, Missouri, United States

Site Status

Carolinas Center for Liver Disease

Charlotte, North Carolina, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Thomas Jefferson University, Gastroenterology and Hepatology

Philadelphia, Pennsylvania, United States

Site Status

Northwest Medical Specialties, PLLC Infections Limited, P.S.

Tacoma, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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FA-788-0004

Identifier Type: -

Identifier Source: org_study_id