Trials / Completed
CompletedNCT00047814
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
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 48 (planned)
- Sponsor
- Astellas Pharma Inc · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | FK788 |
Timeline
- Start date
- 2002-10-01
- Completion
- 2006-03-01
- First posted
- 2002-10-24
- Last updated
- 2011-12-09
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00047814. Inclusion in this directory is not an endorsement.