## Protocol Section
### Identification Module
**NCT ID:** NCT01337479

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

**Official Title:** 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

#### Organization Study ID Info
**ID:** AI463-049
#### Organization
**Class:** INDUSTRY
**Full Name:** Bristol-Myers Squibb
### Status Module
#### Completion Date
**Date:** 2010-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2011-04-19

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-04-18

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-09

**Type:** ACTUAL

#### Start Date
**Date:** 2003-02

**Status Verified Date:** 2011-04

#### Study First Post Date
**Date:** 2011-04-19
**Type:** ESTIMATED
**Study First Submit Date:** 2011-04-15
**Study First Submit QC Date:** 2011-04-18
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Bristol-Myers Squibb

#### Responsible Party

**Old Name Title:** Study Director

**Old Organization:** Bristol-Myers Squibb

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Hepatitis B

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 1097

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Those who participated in the specific Phase III entecavir studies as described; all had Hepatitis B infections

**Label:** Participants of specific phase III entecavir studies

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)

**Time Frame:** data is collected every 6 months

#### Secondary Outcomes

**Measure:** 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

**Measure:** 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

**Measure:** 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

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

**Time Frame:** Every 6 months

**Measure:** To determine all cause mortality by the phase III treatment group

**Time Frame:** Every 6 months

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

**Time Frame:** Every 6 months

**Measure:** To determine Non-hepatic malignancies by the phase III treatment group

**Time Frame:** Every 6 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

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

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Only subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.

### Contacts Locations Module

#### Overall Officials

**Official 1:**

**Affiliation:** Bristol-Myers Squibb

**Name:** Bristol-Myers Squibb

**Role:** STUDY_DIRECTOR

### References Module

#### See Also Links

**Label:** BMS Clinical Trials Disclosure

**URL:** http://www.bms.com/clinical_trials/Pages/home.aspx

**Label:** For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm

**URL:** http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000008107

- Term: Liver Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000006525

- Term: Hepatitis, Viral, Human

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000004769

- Term: Enterovirus Infections

- ID: D000010850

- Term: Picornaviridae Infections

- ID: D000012327

- Term: RNA Virus Infections

- ID: D000086982

- Term: Blood-Borne Infections

- ID: D000003141

- Term: Communicable Diseases

- ID: D000018347

- Term: Hepadnaviridae Infections

- ID: D000004266

- Term: DNA Virus Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9592

- Name: Hepatitis A

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9595

- Name: Hepatitis B

- Relevance: HIGH

- As Found: Hepatitis B

- ID: M21609

- Name: Hepatitis B, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M9591

- Name: Hepatitis

- Relevance: HIGH

- As Found: Hepatitis

- ID: M9607

- Name: Hepatitis, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M11107

- Name: Liver Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9610

- Name: Hepatitis, Viral, Human

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7930

- Name: Enterovirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M13745

- Name: Picornaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15149

- Name: RNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M2593

- Name: Blood-Borne Infections

- Relevance: LOW

- As Found: Unknown

- ID: M20487

- Name: Hepadnaviridae Infections

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000006506

- Term: Hepatitis A

- ID: D000006509

- Term: Hepatitis B

- ID: D000006505

- Term: Hepatitis

### Intervention Browse Module - Browse Branches

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M21243

- Name: Lamivudine

- Relevance: LOW

- As Found: Unknown

- ID: M211592

- Name: Entecavir

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
