Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00047814

Enrollment

Registered

2002-10-24

Start date

2002-10-31

Completion date

2006-03-31

Last updated

2011-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

HCV

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.

Interventions

DRUGFK788

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion 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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026