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
1 other identifier
observational
1,097
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2003
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 15, 2011
CompletedFirst Posted
Study publicly available on registry
April 19, 2011
CompletedApril 19, 2011
April 1, 2011
7.6 years
April 15, 2011
April 18, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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
- +2 more secondary outcomes
Study Arms (1)
Participants of specific phase III entecavir studies
Those who participated in the specific Phase III entecavir studies as described; all had Hepatitis B infections
Eligibility Criteria
Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
You may qualify if:
- All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 15, 2011
First Posted
April 19, 2011
Study Start
February 1, 2003
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
April 19, 2011
Record last verified: 2011-04