NCT00362635已完成3 期
A Double-blinded and Randomised Study to Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30 mg qd Versus Lamivudine 100 mg qd for Chronic Hepatitis B Infection
Bukwang Pharmaceutical2 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2006年8月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR
研究概览
简要总结
The purpose of this study is to compare the efficacy and safety of 48-week treatment with Clevudine 30 mg qd versus lamivudine 100 mg qd for chronic hepatitis B infection.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is between 18 and 60, inclusive.
- •Patient is HBV DNA positive with DNA levels at screening >= 3 x 1,000,000 copies/mL.
- •Patient is documented to be HBsAg positive for > 6 months and HBeAg positive.
- •Patient has AST and ALT levels which are >= 1 times and <= 10 times the upper limit of normal (x ULN).
- •Patient has bilirubin levels <= 1.5 x ULN or bilirubin levels > 1.5 x ULN with diagnosis of Gilbert's disease and conjugated bilirubin within normal limits.
- •Women of childbearing age must have a negative urine (b-HCG) pregnancy test before start of trial treatment.
- •Patient is able to give written informed consent prior to study start and to comply with the study requirements.
排除标准
- •Patient is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- •Patients previously treated with lamivudine, lobucavir, adefovir, famciclovir, or any other investigational nucleoside for HBV infection.
- •Previous treatment with interferon must have ended at least 6 months prior to the screening visit.
- •Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- •Patient is co-infected with HCV or HIV.
- •Patient has evidence of decompensated cirrhosis or hepatocellular carcinoma (alpha fetoprotein).
- •Patient is pregnant or breast-feeding.
- •Patient is unwilling to use an "effective" method of contraception during the study and for up to 3 months after the use of study drug ceases. For males, condoms should be used. Females must be surgically sterile (via hysterectomy or bilateral tubal ligation), post-menopausal, or using at least a medically acceptable barrier method of contraception (i.e., IUD, barrier methods with spermicide or abstinence).
- •Patient has a clinically relevant history of abuse of alcohol or drugs.
- •Patient has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
- •Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to Screening Visit.
- •Subjects who are taking any traditional Chinese medication, or has been taking any traditional Chinese medication within the last 2 weeks prior to Screening Visit.
- •Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol.
结局指标
主要结局
Efficacy: incident rate of the HBV DNA negativity (i.e. <300 copies/ml) by PCR
Safety: Laboratory tests, Adverse Events, Physical examination
次要结局
- Efficacy:
- Viral kinetics of HBV DNA suppression
- Viral dynamic study over the first 12 weeks to define the nature of the anti-viral effect of Clevudine compared to Lamivudine.
- Evaluation of the changes of ALT normalization rate and HBV serology over 48 weeks of treatment period
- Evaluation of the proportion of patients with HBV DNA <300 copies/ml, median HBV DNA change from baseline(log10 copies/ml), the proportion of patients with normal ALT, and HBV serology over an additional 48 weeks of open label treatment
研究者
研究点 (2)
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