Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
This study has been completed.
Sponsor:
Astellas Pharma Inc
Collaborator:
Astellas Pharma US, Inc.
Information provided by:
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00047814
First received: October 18, 2002
Last updated: December 8, 2011
Last verified: December 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Drug: FK788 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection |
Resource links provided by NLM:
Further study details as provided by Astellas Pharma Inc:
| Estimated Enrollment: | 48 |
| Study Start Date: | October 2002 |
| Study Completion Date: | March 2006 |
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00047814
Locations
| United States, California | |
| Liver Center Huntington Memorial Hospital | |
| Pasadena, California, United States, 91105 | |
| United States, Colorado | |
| Rocky Mount Gastroenterology | |
| Lakewood, Colorado, United States, 80215 | |
| United States, Florida | |
| University of Florida and Shands Hospital | |
| Gainsville, Florida, United States, 32610 | |
| United States, Massachusetts | |
| Liver Center BIDMC - Harvard | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Missouri | |
| Gastroenterology and Hepatology | |
| Kansas City, Missouri, United States, 64131 | |
| United States, North Carolina | |
| Carolinas Center for Liver Disease | |
| Charlotte, North Carolina, United States, 28203 | |
| Duke University | |
| Durham, North Carolina, United States, 27705 | |
| United States, Pennsylvania | |
| Thomas Jefferson University, Gastroenterology and Hepatology | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| United States, Washington | |
| Northwest Medical Specialties, PLLC Infections Limited, P.S. | |
| Tacoma, Washington, United States, 98405 | |
Sponsors and Collaborators
Astellas Pharma Inc
Astellas Pharma US, Inc.
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00047814 History of Changes |
| Other Study ID Numbers: | FA-788-0004 |
| Study First Received: | October 18, 2002 |
| Last Updated: | December 8, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Astellas Pharma Inc:
|
HCV |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Virus Diseases Hepatitis C, Chronic Liver Diseases |
Digestive System Diseases Hepatitis, Viral, Human Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on June 17, 2013