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

Bristol-Myers Squibb1,097 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

1,097

Conditions

Hepatitis B

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

Outcomes

Primary Outcomes

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

Time frame: data is collected every 6 months

Secondary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: Every 6 months

To determine the number of anti-HBV medications following enrollment in AI463049 by the phase III treatment group

Time frame: Every 6 months

To determine all cause mortality by the phase III treatment group

Time frame: Every 6 months

To determine HBV-related mortality by the phase III treatment group

Data from ClinicalTrials.gov

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