NCT00313261终止2 期
An Open-Label, Phase II Study to Evaluate Safety, Tolerability, Antiviral Activity and Biochemical and Immunological Responses of L-FMAU (Clevudine) in Chronic Hepatitis B Patients of L-FMAU-201 Placebo Group
Bukwang Pharmaceutical14 个研究点 分布在 2 个国家开始时间: 2003年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 试验地点
- 14
- 主要终点
- Efficacy: Change from baseline in HBV DNA (log10)
研究概览
简要总结
The purpose of this study is to evaluate the safety and antiviral activity of clevudine 30 mg QD for treatment of longer period (24 weeks) in patients chronically infected with HBV.
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
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who received placebo in L-FMAU-201 study
- •Female of childbearing potential with a negative serum (beta-HCG) pregnancy test within 14 days of starting therapy.
- •Patients who were able to give written informed consent prior to study start and to comply with the study requirements.
- •Patients who met the following criteria after completion of the Week 48 visit were to have additional follow-up visits at Weeks 54 and 60:
- •had received no additional therapy since completion of 24-week treatment of clevudine and 2)experienced a >= 1 log10 decrease from baseline in HBV DNA at Week 48
排除标准
- •Patient with HBeAg seroconverted to anti-HBe at the last 2 consecutive visits (one month apart) in L-FMAU-201 study.
- •Patient who was currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- •Patient who was treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection after cessation of treatment in L-FMAU-201 study.
- •Patient who had a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- •Patient who was co-infected with HCV, HDV or HIV.
- •Patient with clinical evidence of cirrhosis or hepatocellular carcinoma (®-Fetoprotein)Evaluation was based on alpha-fetoprotein primarily. If alpha-fetoprotein level was suggestive of cirrhosis or hepatocellular carcinoma, confirmation was made with ultrasonography etc.
- •Patient who was pregnant or breast-feeding.
- •Patient who was unwilling to use an "effective" method of contraception during treatment period and for up to 3 months after cessation of therapy. 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 supermicide or abstinence)
- •Patient who had a clinically relevant history of abuse of alcohol or drugs.
- •Patient who had a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
- •Patient who had creatinine clearance less than 60mL/min as estimated by the following formula:
- •(140-age in years) (body weight [kg])/(72) (serum creatinine [mg/dL]) [Note: multiply estimates by 0.85 for women]
结局指标
主要结局
Efficacy: Change from baseline in HBV DNA (log10)
Safety: Laboratory tests, Adverse Events, Vital Signs, ECG
次要结局
- Efficacy
- Proportion of patients with HBV DNA below the assay Limit of Detection (4,700 copies/mL by Digene Hybrid Capture II)
- Biochemical improvement (ALT normalization)
- Serology Proportion of patients with HBeAg loss Seroconversion rate (HBeAg loss and anti-HBe gain)
研究者
研究点 (14)
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