NCT00124241已完成2 期
A Phase IIb Extension Study of LdT (Telbivudine), Lamivudine or LdT Plus Lamivudine in Patients With Chronic Hepatitis B Who Have Completed Study NV-02B-003
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Novartis
- 试验地点
- 4
研究概览
简要总结
This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has completed protocol NV-02B-003 without a serious adverse event attributed to study drug
- •Patient remains seropositive for hepatitis B surface antigen (HBsAg)
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Patient is pregnant or breast-feeding
- •Patient has signs of decompensated chronic hepatitis B
- •Other protocol-defined exclusion criteria may apply.
研究者
研究点 (4)
Loading locations...
相似试验
已完成
2 期
An Extension Study of the Safety and Anti-leukemic Effects of Imatinib Mesylate in Participants With Philadelphia Chromosome-positive Chronic Myeloid Leukemia in Blast CrisisPhiladelphia Chromosome Positive CMLNCT00171158Novartis Pharmaceuticals260
已完成
3 期
Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis BChronic Hepatitis BNCT00131742Novartis
已完成
3 期
Therapeutic Use of Tadekinig Alfa in NLRC4 Mutation and XIAP Deficiency As Open Label ExtensionXIAP DeficiencyNLRC4-MASNCT03512314AB2 Bio Ltd.11
已完成
2 期
24-week Open-label Extension Study Evaluating PXT00864 Effect in Mild AD Patients Further to PLEODIAL-I CompletionAlzheimer DiseaseNCT02361242Pharnext S.C.A.45
已完成
2 期
A Study of TAK-994 in Adults with Narcolepsyarcolepsy Type 1 (NT 1)JPRN-jRCT2071210015onomura Hidenori26