NCT00395018已完成3 期
Study of the Antiviral Activity of Entecavir in Patients Receiving Liver Transplant Due to Chronic Hepatitis B Virus Infection
Bristol-Myers Squibb10 个研究点 分布在 2 个国家目标入组 109 人开始时间: 2007年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 109
- 试验地点
- 10
- 主要终点
- Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72
研究概览
简要总结
The purpose of this clinical research study is to learn if the study drug entecavir will prevent the recurrence of hepatitis B virus (HBV) in participants who receive an orthotopic liver transplant (OLT) due to HBV infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients receiving orthotopic liver transplant (OLT) due to end-stage liver disease because of chronic HBV infection, with HBV-DNA < 172 IU/mL (approximately < 1000 copies/mL) prior to liver transplant
- •Must have detectable hepatitis B surface antigen (HBsAg) at screening and for at least 24 weeks prior to screening
排除标准
- •Patients with hepatocellular carcinoma with evidence of extrahepatic spread, multiple tumors ≥ 6.5 cm in diameter or there is up to three nodules ≥ 4.5 cm in diameter and total tumor diameter is ≥ 8 cm
- •Co-infection with human immunodeficiency virus (HIV), cytomegalovirus (CMV), Epstein-Barr virus (EBV) or hepatitis C virus (HCV)
研究组 & 干预措施
entecavir
Experimental
干预措施: entecavir (Drug)
结局指标
主要结局
Percentage of Participants With HBV Deoxyribonucleic Acid (DNA) => 50 IU/mL by Polymerase Chain Reaction (PCR) at Week 72
时间窗: At 72 weeks
HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.
Number of Participants With HBV DNA by PCR >= 50 IU/mL Through Week 72
时间窗: At baseline (day 1), week 12, 24, 36, 48, 60, and 72
HBV DNA assessments were performed using the Roche COBAS® TaqMan High+Pure system (HPS) assay. HBV DNA =\> 50 IU/mL = approximately =\> 300 copies/mL.
次要结局
- Distribution of ALT Levels Through 72 Weeks: Overall(On Day 1 (baseline) and at week 4, 12, 24, 36, 48, 60, 72)
- Percentage of Participants With HBV DNA < 50 IU/mL (Approximately 300 Copies/mL) by PCR at the End of Post-dosing Follow-up(At 72 weeks + 24 weeks follow-up)
- Percentage of Participants With HBeAg Loss at Week 72 (for HBeAg-positive Participants)(At week 72)
- Percentage of Participants With HBeAg Seroconversion at Week 72 (for HBeAg-positive Participants)(At week 72)
- Percentage of Participants With HBsAg Loss at Week 72(At week 72)
- Percentage of Participants With HBsAg Seroconversion at Week 72(At week 72)
- Percentage of Participants With HBsAg Recurrence At Week 72(At week 72)
- Total Bilirubin at Week 72(At week 72)
- Prothrombin Time (PT) at Week 72(At week 72)
- Number of Participants With Liver Rejection Through Week 72(Through week 72)
- Number of Participants With Re-transplantation Through Week 72(Through week 72)
- Participants With Adverse Events (AE), Serious Adverse Events (SAE), and Discontinuations From Study Drug Due to AEs (On-treatment [OT] and Off-treatment Follow-up [OF])(OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up)
- Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment Follow-up(OF): Hematology (All Grades)(OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up)
- Number of Participants With Laboratory Abnormalities On-treatment (OT) and Off-Treatment (OF) Follow-up: Serum Chemistry (All Grades)(OT:From start of dosing through Week 72 + 5 days; OF:End of OT through 24-weeks follow-up)
研究者
研究点 (10)
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