Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047814
Status:
COMPLETED
Last Update Posted:
2011-12-09
First Post:
2002-10-18
Brief Title:
Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Multiple Rising-Dose Study of FK788 in Subjects With Chronic Hepatitis C Virus Infection
Status:
COMPLETED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None