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| Sponsors and Collaborators: |
Astellas Pharma Inc Astellas Pharma US, Inc. |
| Information provided by: | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier: | NCT00047814 |
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 II |
| MedlinePlus related topics: | Hepatitis Hepatitis C |
| Drug Information available for: | FK 788 |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study |
| Official Title: | A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection |
| Estimated Enrollment: | 48 |
| Study Start Date: | October 2002 |
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 |
The following criteria is a brief summary of Criterion required for trial participation.
Inclusion Criteria
Exclusion Criteria
Contacts and 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 | |||||
| Duke University | |||||
| Durham, North Carolina, United States, 27705 | |||||
| Carolinas Center for Liver Disease | |||||
| Charlotte, North Carolina, United States, 28203 | |||||
| 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 | |||||
| Astellas Pharma Inc |
| Astellas Pharma US, Inc. |
More Information
| Study ID Numbers: | FA-788-0004 |
| First Received: | October 18, 2002 |
| Last Updated: | July 28, 2008 |
| ClinicalTrials.gov Identifier: | NCT00047814 |
| Health Authority: | United States: Food and Drug Administration |
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