Randomized, Double-Blind Trial of Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Number of Participants With Clinical Response
研究概览
简要总结
This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the treatment of Hepatitis B infection. The results for patients taking LdT will be compared to results for patients taking lamivudine.
详细描述
Multicenter, multinational, randomized, double-blind study designed to compare the safety and efficacy of telbivudine (600 mg/day) versus lamivudine (100 mg/day) for 104 weeks in adults with decompensated chronic hepatitis B and evidence of cirrhosis. Patients were pre-stratified by screening Child-Turcotte-Pugh score (CTP score < 9 or ≥ 9) and ALT level (within normal limits (WNL) or > 1.0 x ULN) to help assure similar degrees of hepatic insufficiency and liver inflammation on both treatment arms. After 104 weeks of treatment, participants were followed-up with for an additional 16 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented decompensated chronic hepatitis B defined by all of the following:
- •Clinical history compatible with decompensated chronic hepatitis B related cirrhosis;
- •Child-Turcotte-Pugh score > 7 points.
- •Evidence of hepatic cirrhosis or portal hypertension.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Patient is pregnant or breastfeeding.
- •Patient is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV), or Human immunodeficiency virus (HIV).
- •Patient previously received lamivudine, adefovir, or an investigational anti-hepatitis B virus (HBV) nucleoside or nucleotide analog at any time
- •Patient has received interferon or other immunomodulatory treatment for HBV infection in the 12 months before Screening for this study.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Telbivudine 600 mg
Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
干预措施: Telbivudine (Drug)
Telbivudine 600 mg
Participants received Telbivudine 600 mg and a matching lamivudine placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
干预措施: Placebo (Drug)
Lamivudine 100 mg
Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
干预措施: Lamivudine (Drug)
Lamivudine 100 mg
Lamivudine 100 mg and a Telbivudine matching placebo orally once a day for up to 104 weeks. Participants were followed-up for 16 weeks post-treatment.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Clinical Response
时间窗: From Baseline to Week 52
Clinical response defined as achieving all of the following 3 criteria on at least 2 consecutive visits or at the last on-treatment visit: Serum hepatitis B virus (HBV) DNA \< 4 log10 copies/mL, normal Alanine transaminase (ALT) level (ALT ≤ Upper Limit of Normal (ULN)), and improvement (a 2- point or greater reduction in Child-Turcotte-Pugh (CTP) score) or stabilization (not more than a 1-point change in CTP score), compared to the baseline value. CTP scores range from 5-15, higher scores indicate more liver impairment. For Improvement/Stabilization, either of the individual criteria were met.
次要结局
- Time to Initial Clinical Response(From Baseline to Week 104)
- Duration of Initial Clinical Response(Baseline to Week 104)
- Number of Participants With Improvement, Stabilization, and Worsening in Child-Turcotte-Pugh (CTP) Score at Week 52 and Week 104(From Baseline to weeks 52 and 104)
- Number of Participants With Improvement, Stabilization, and Worsening in a Modified (3-component) CTP Score(Baseline and Week 104)