A Phase IIIb: Long-Term Outcomes for Hepatitis B (HepB) Patients in Some Previous Entecavir (ETV) Trials

Study Overview
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Brief Summary
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The purpose of this study is to follow patients treated in entecavir Phase III and rollover studies for safety experience and Hepatitis B virus (HBV)-related complications.

Detailed Description
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Observational Model: Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027. Number of groups/cohorts: 1 (All subjects were observed in the same manner).

Official Title
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Long-Term Assessment of Treatment Outcomes With Entecavir and Lamivudine for Chronic Hepatitis B Infection in Patients Who Have Enrolled in Phase III Entecavir Trials

Conditions
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Hepatitis B

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants of specific phase III entecavir studies<br>Those who participated in the specific Phase III entecavir studies as described; all had Hepatitis B infections | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups) | defined as follows: Hepatic cirrhosis (Diagnosis requires biopsy or imaging study) Esophageal Varices (Grade 1 or higher on endoscopy or barium swallow) Bleeding esophageal varices Ascites (Present on physical exam or imaging study) Hepatic encephalopathy (≥ Stage 2) Hepatocellular carcinoma Spontaneous bacterial peritonitis Gastric varices Bleeding gastric varices Hepatorenal syndrome | data is collected every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the proportion of subjects who have a HBV Deoxyribonucleic acid (DNA) by Polymerase chain reaction (PCR) of < 300 copies/mL over the AI463049 follow-up period by the phase III treatment group |  | Every 6 months | 
| To determine the proportion of subjects who have Alanine transaminase (ALT) ≤ 1.0 x Upper limit of normal (ULN) over the AI463049 follow-up period by the phase III treatment group |  | Every 6 months | 
| To determine the proportion of subjects who were Hepatitis B e antigen (HBeAg) positive at the beginning of Phase III trials who have HBeAg loss or HBe seroconversion over the AI463049 follow-up period by the phase III treatment group |  | Every 6 months | 
| To determine the number of anti-HBV medications following enrollment in AI463049 by the phase III treatment group |  | Every 6 months | 
| To determine all cause mortality by the phase III treatment group |  | Every 6 months | 
| To determine HBV-related mortality by the phase III treatment group |  | Every 6 months | 
| To determine Non-hepatic malignancies by the phase III treatment group |  | Every 6 months |