Virological Response Study of the HCV Vaccine IC41
This study has been completed.
Information provided by (Responsible Party):
First received: January 4, 2008
Last updated: October 18, 2012
Last verified: October 2012
The objective is to investigate the virological (HCV-RNA) responses following biweekly immunization with IC41.
Treatment phase 14 weeks, total study duration including follow-up period 38 weeks.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV|
Resource links provided by NLM:
Further study details as provided by Intercell AG:
Primary Outcome Measures:
- HCV-RNA 2 weeks after end of treatment [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Immunological assays and Safety [ Time Frame: until study end ] [ Designated as safety issue: Yes ]
|Study Start Date:||February 2006|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
8 injections of 4 x 0.125mL
Contacts and Locations