NCT00606099撤回4 期
A 26 Week Randomized, Open Label, Multi-center Study of the Efficacy and Safety of Telbivudine 600 mg Once Daily Versus Adefovir Dipivoxil 10mg Once Daily in Subjects With Compensated Chronic Hepatitis B and Sub-optimal Response to at Least 48 Weeks of Adefovir Dipivoxil 10 mg
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Novartis
- 试验地点
- 1
- 主要终点
- Efficacy at 24 weeks of treatment.
研究概览
简要总结
This study is designed to evaluate the efficacy and safety of telbivudine 600mg versus adefovir dipivoxil 10mg in patients with compensated chronic 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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, at least 18 years of age.
- •Patients with compensated chronic hepatitis B who are currently receiving adefovir 10mg once daily.
- •Patients must have received adefovir 10mg once daily for at least 48 weeks continuously and have a sub-optimal response to adefovir therapy (≥4log10 copies of HBV DNA/mL).
- •Patient is willing to comply with all study requirements.
- •Patient is willing and able to provide written informed consent.
排除标准
- •Pregnant or nursing (lactating) women. All women must have a negative pregnancy test at the screening visit.
- •Female patients of reproductive potential is unwilling to use double barrier method of contraception (condom plus spermicide or diaphragm plus spermicide).
- •Patient is co-infected with hepatitis C virus or HIV.
- •Patient has previously taken lamivudine.
- •Patient is currently abusing illicit drugs or alcohol.
- •Patient is using any investigational drugs or with in the last 30 days.
- •Patient is enrolled or plans to enroll in a clinical study involving investigational drug.
- •Patient has a history of pancreatitis, hepatic decompsensation, Hepatocellular Carcinoma, or a history of hypersensitivity to telbivudine or adfovir.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
1
Experimental
telbivudine
干预措施: telbivudine (Drug)
2
Active Comparator
adefovir dipivoxil
干预措施: adefovir dipivoxil (Drug)
结局指标
主要结局
Efficacy at 24 weeks of treatment.
时间窗: 1 yr
次要结局
- To compare biochemical response at week 24 of treatment. To compare changes in viral load at week 24 of treatment. To compare the rate and pattern of treatment-emergent Hepatitis B virus (HBV) viral genotypic mutations after 24 weeks of treatment.(1yr)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of CirrhosisHepatitis B, ChronicHepatitisCirrhosisNCT00076336Novartis Pharmaceuticals232
终止
3 期
Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)Hepatitis BNCT00412750Novartis159
已完成
3 期
Telbivudine Versus Adefovir Dipivoxil in Adults With HBegAg-Positive, Compensated Chronic Hepatitis BChronic Hepatitis BNCT00115245Novartis
撤回
4 期
Trial of Telbivudine Combination Therapy vs. Continued Adefovir MonotherapyChronic Hepatitis BNCT00409019Novartis Pharmaceuticals
已完成
4 期
A Study With Clevudine Monotherapy or Adefovir and Clevudine Combination in Proportion to Roadmap Concept in Patients With HBV Associated-HCCHepatitis B Associated Hepatocellular CarcinomaNCT01263002Bukwang Pharmaceutical33