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Tracking Information | |||||
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First Received Date † | January 4, 2008 | ||||
Last Updated Date | January 15, 2008 | ||||
Start Date † | February 2006 | ||||
Current Primary Outcome Measures † |
HCV-RNA 2 weeks after end of treatment | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00601770 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Immunological assays and Safety | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Virological Response Study of the HCV Vaccine IC41 | ||||
Official Title † | Open-Label, Multicenter Trial With IC41, a Therapeutic HCV Vaccine in Patients With Chronic HCV | ||||
Brief Summary | 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. |
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Detailed Description | |||||
Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
Condition † | Chronic Hepatitis C | ||||
Intervention † | Biological: IC41 | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Estimated Enrollment † | 70 | ||||
Estimated Completion Date | July 2008 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 55 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | |||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00601770 | ||||
Responsible Party | Intercell AG, Intercell AG | ||||
Secondary IDs †† | |||||
Study Sponsor † | Intercell AG | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Intercell AG | ||||
Verification Date | October 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |