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
1 other identifier
interventional
48
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Oct 2002
Typical duration for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2002
CompletedFirst Submitted
Initial submission to the registry
October 18, 2002
CompletedFirst Posted
Study publicly available on registry
October 24, 2002
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedDecember 9, 2011
December 1, 2011
October 18, 2002
December 8, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- Astellas Pharma US, Inc.collaborator
Study Sites (9)
Liver Center Huntington Memorial Hospital
Pasadena, California, 91105, United States
Rocky Mount Gastroenterology
Lakewood, Colorado, 80215, United States
University of Florida and Shands Hospital
Gainsville, Florida, 32610, United States
Liver Center BIDMC - Harvard
Boston, Massachusetts, 02215, United States
Gastroenterology and Hepatology
Kansas City, Missouri, 64131, United States
Carolinas Center for Liver Disease
Charlotte, North Carolina, 28203, United States
Duke University
Durham, North Carolina, 27705, United States
Thomas Jefferson University, Gastroenterology and Hepatology
Philadelphia, Pennsylvania, 19107, United States
Northwest Medical Specialties, PLLC Infections Limited, P.S.
Tacoma, Washington, 98405, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 18, 2002
First Posted
October 24, 2002
Study Start
October 1, 2002
Study Completion
March 1, 2006
Last Updated
December 9, 2011
Record last verified: 2011-12