Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

Hepatitis C Clinical Trial

Official title:

A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00047814
• Other study ID #: FA-788-0004
• Status: Completed
• Phase: Phase 2
• First received: October 18, 2002
• Last updated: December 8, 2011
• Start date: October 2002
• Est. completion date: March 2006

Study information

• Verified date: December 2011
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Virus Diseases

Intervention

Drug:
• FK788

Locations

Country	Name	City	State
United States	Liver Center BIDMC - Harvard	Boston	Massachusetts
United States	Carolinas Center for Liver Disease	Charlotte	North Carolina
United States	Duke University	Durham	North Carolina
United States	University of Florida and Shands Hospital	Gainsville	Florida
United States	Gastroenterology and Hepatology	Kansas City	Missouri
United States	Rocky Mount Gastroenterology	Lakewood	Colorado
United States	Liver Center Huntington Memorial Hospital	Pasadena	California
United States	Thomas Jefferson University, Gastroenterology and Hepatology	Philadelphia	Pennsylvania
United States	Northwest Medical Specialties, PLLC Infections Limited, P.S.	Tacoma	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Astellas Pharma Inc	Astellas Pharma US, Inc.

Country where clinical trial is conducted

United States,