Table of Contents
Clinical Trial Design Issues for Drugs to Treat CHB
Why Now?
Meeting Focus
Key Issues
Agenda: Aug. 7, 2002
Clinical Trial Design Issues in CHB Drug Development
Key Issues Compensated and Decompensated CHB
Patient Populations Essential for Marketing Applications
Patient Populations Study Inclusion Criteria
Selection of Controls
Choice of Primary Endpoint Compensated CHB
Choice of Primary Endpoint Decompensated
Endpoints
Endpoint Considerations In addition to endpoint choice...
Outcomes at 48 and 72 wks Adefovir Study 437
Endpoint Validation against histology
Endpoint Validation
HBV DNA change and Histology Studies Analyzed
PPT Slide
Endpoint Validation FDA Analyses
Long-term follow-up
Questions To The Committee
Patient Population
Cont. Patient Population
Control Arms
Cont. Control Arms
Study Endpoints and Timing of Evaluation
Cont. Endpoints...
Cont. Endpoints...
Cont. Endpoints...
Cont. Endpoints...
Long Term Follow-Up
PPT Slide
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