Clinical trial NCT00047814: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Keywords: HCV
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: Astellas Pharma US, Inc.
First posted: 2002-10-24
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Liver Center Huntington Memorial Hospital
state: California
city: Lakewood
country: United States
facility: Rocky Mount Gastroenterology
state: Colorado
city: Gainsville
country: United States
facility: University of Florida and Shands Hospital
state: Florida
city: Boston
country: United States
facility: Liver Center BIDMC - Harvard
state: Massachusetts
city: Kansas City
country: United States
facility: Gastroenterology and Hepatology
state: Missouri
city: Charlotte
country: United States
facility: Carolinas Center for Liver Disease
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Philadelphia
country: United States
facility: Thomas Jefferson University, Gastroenterology and Hepatology
state: Pennsylvania
city: Tacoma
country: United States
facility: Northwest Medical Specialties, PLLC Infections Limited, P.S.
state: Washington
Study officials:
References: