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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants of specific phase III entecavir studies | Those who participated in the specific Phase III entecavir studies as described; all had Hepatitis B infections |
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| 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:
| data is collected every 6 months |
| 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 |
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Inclusion Criteria:
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Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
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| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
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| Label | URL |
|---|---|
| BMS Clinical Trials Disclosure | View source |
| For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm | View source |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| 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 |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |