NCT00313274终止3 期
A Double-Blind, Randomized, Parallel, Placebo-Controlled Phase III Study to Evaluate the Safety and Antiviral Activity of Clevudine (L-FMAU) 30 mg QD in Patients With HBeAg Negative Chronic Hepatitis B
Bukwang Pharmaceutical58 个研究点 分布在 2 个国家目标入组 80 人开始时间: 2003年7月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 80
- 试验地点
- 58
- 主要终点
- Safety:
研究概览
简要总结
The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative
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
- •Patients who were between 18 and 60, inclusive
- •Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
- •Patients who were documented to be HBsAg positive for > 6 months (documentation of positive HBsAg for the previous 6 months included previous laboratory reports showing HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and IgG anti-HBc positive at screening).
- •Patients who were HBeAg negative and HBeAb positive.
- •Patients with ALT levels which were in the range of ≥1.2 and < 15 times the upper limit of normal (ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL.
- •Women of childbearing potential with a negative serum (β-HCG) pregnancy test taken 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.
排除标准
- •Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- •Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
- •Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- •Patients coinfected with HCV, HDV or HIV.
- •Patients with clinical evidence of liver mass or with alfa-fetoprotein > 50 ng/mL
- •Patients who were pregnant or breast-feeding.
- •Patients who were unwilling to use an "effective" method of contraception during the treatment period and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence)
- •Patients with a clinically relevant history of abuse of alcohol or drugs.
- •Patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
- •Patients with 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
Safety:
Laboratory tests
ECG
Efficacy:
Antiviral activity (change from baseline in HBV DNA (log 10))
Adverse Events
Vital signs
次要结局
- Efficacy
- Antiviral activity: proportion of patients with HBV DNA below the assay limit of detection (<4,700 copies/mL by Digene Hybrid Capture II assay)
- Biochemical improvement (e.g. ALT normalization )
研究者
研究点 (58)
Loading locations...
相似试验
终止
3 期
Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patient With Chronic HBVHepatitis BNCT00313287Bukwang Pharmaceutical180
已完成
2 期
The Proof of Concept Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Mild and Moderate COVID-19COVID-19NCT04891302Bukwang Pharmaceutical104
终止
2 期
Safety and Antiviral Activity of Clevudine in Patients Infected With Hepatitis B VirusHepatitis BNCT00305019Bukwang Pharmaceutical120
已完成
2 期
The Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19COVID-19NCT04347915Bukwang Pharmaceutical64
已完成
3 期
Compare the Efficacy and Safety of 48-week Treatment With Clevudine 30mg Versus Lamivudine 100mg for CHB InfectionHepatitis BNCT00362635Bukwang Pharmaceutical92