Clinical Trial Design Issues for Drugs to Treat CHB

8/14/02


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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

Author: CDER USER