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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,097
- 主要终点
- The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects who participated in Entecavir Phase III studies AI463022, AI463023, AI463026, and AI463027.
排除标准
- 未提供
结局指标
主要结局
The proportion of subjects who have newly reported hepatitis B-related complications during AI463049 (reported by Phase III treatment groups)
时间窗: 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
次要结局
- 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)