FDA Advisory Meeting Clinical Trial Design – Hepatitis B Treatment

8/14/02


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Table of Contents

FDA Advisory Meeting Clinical Trial Design – Hepatitis B Treatment

TREATMENT OF CHRONIC HEPATITIS B

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Review of Clinical Trials of IFN and Lamivudine

Sentinel Clinical Trials of IFN and LAM in HBeAg + CHB

‘Sentinel’ Clinical Trials of IFN and LAM in HBeAg- CHB

Meta-analysis of 24 RCTs of IFN in HBeAg+ CHB

Meta-analysis of 12 Studies of IFN Rx on Long-Term Outcome of HBeAg+ Adults#

IFN Rx of HBeAg+ CHB

IFN Treatment of HBeAg - CHB

IFN Treatment of HBeAg - CHB Cumulative results of published studies

IFN Rx of HBeAg - CHB: Histologic Response

IFN Rx of HBeAg- CHB

Lamivudine Rx of HBeAg+ CHB

Lamivudine Rx of HBeAg+ CHB

Lamivudine Rx of HBeAg+ CHB

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Treatment of HBeAg - CHB

Treatment of Decompensated Cirrhosis

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Clinical Practice Guidelines

AASLD Practice Guidelines

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AASLD Practice Guidelines Treatment Regimen - IFN

AASLD Practice Guidelines Treatment Regimen - Lamivudine

Issues for Future Clinical Trials

Issues for Future Clinical Trials

Issues for Future Clinical Trials

Issues for Future Clinical Trials

Issues for Future Clinical Trials

Issues for Future Clinical Trials

Issues for Future Clinical Trials

Ability of Surrogate Markers to Predict Clinical Outcome

IFN Rx of HBeAg+ CHB

Impact of HBeAg Clearance on Long-Term Clinical Outcome

Cumulative Transplant-Free Survival of Patients with HBeAg- Chronic Hepatitis

Correlation Between Week 52 HBV DNA Levels and HBeAg Seroconversion in Lamivudine Trials NUCB 3009/NUCA 3010

Correlation between Week 52 HBV DNA Levels and ALT Normalization Lamivudine Trials NUCB 3009/NUCA 3010

Correlation Between Week 52 HBV DNA Levels and Histologic Response Lamivudine Trials NUCB 3009/NUCA 3010

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Correlation Between Week 48 HBV DNA, ALT and Histologic Response Adefovir Trial GS-438 (e-CHB)

Issues for Future Clinical Trials

Correlation between Week 48 HBeAg loss, HBV DNA, ALT and Histologic Response

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RCTs of IFN Treatment of HBeAg - CHB

IFN Treatment of HBeAg- Patients

Long-Term Follow-Up of HBeAg- Patients with End-of-Treatment Response to IFN

PLA

LAM

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LAM

PLA

LAM

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Author: University Of Michigan