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

Completed

• Conditions: Hepatitis B

• Registration Number: NCT01337479
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

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 Timeline

• Study Start: 2003-02
• Primary Completion: 2010-09
• Study Completion: 2010-09
• Status Verified: 2011-04
• Study First Submitted: 2011-04-15
• Study First Submitted QC: 2011-04-18
• Last Update Submitted: 2011-04-18
• Study First Posted: 2011-04-19
• Last Update Posted: 2011-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1097

Inclusion Criteria

• All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)	data is collected every 6 months	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

Secondary Outcome Measures

Name	Time	Method
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 Non-hepatic malignancies by the phase III treatment group	Every 6 months
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 HBV-related mortality by the phase III treatment group	Every 6 months