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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01337479

Enrollment

1097

Registered

2011-04-19

Start date

2003-02-28

Completion date

2010-09-30

Last updated

2011-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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 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
To determine Non-hepatic malignancies by the phase III treatment group	Every 6 months
To determine all cause mortality by the phase III treatment group	Every 6 months

Outcome results