Safety and Antiviral Activity of Clevudine in Patients Infected With Hepatitis B Virus
A Double- Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety and Antiviral Activity of Clevudine 30 Mg QD and 50 Mg QD Doses in Patients Infected With Hepatitis B Virus
研究概览
研究类型
注册
阶段
- 阶段2
联系人和位置
学习地点
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Guro-ku, Seoul
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Guro-dong、Guro-ku, Seoul、大韩民国、152-703
- Korea University Guro Hospital
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Jongno-Gu, Seoul
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Yeongeon-dong、Jongno-Gu, Seoul、大韩民国、110-744
- Seoul National University
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Kangdong-Gu, Seoul
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Gil-dong、Kangdong-Gu, Seoul、大韩民国、134-701
- Kangdong Sacred Heart Hospital
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Kangnam-Gu, Seoul
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Dogok-dong、Kangnam-Gu, Seoul、大韩民国、146-92
- Yongdong Severance Hospital
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Ilwon-dong、Kangnam-Gu, Seoul、大韩民国、135-710
- Samsung Medical Center
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Songpa-Gu, Seoul
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Pungnab2-dong、Songpa-Gu, Seoul、大韩民国、388-1
- Asan Medical Center
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Yangchon-Gu, Seoul
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Mok-dong、Yangchon-Gu, Seoul、大韩民国、911-1
- Ewha Womans University Hospital
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Yougdungpo-Gu, Seoul
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Youido、Yougdungpo-Gu, Seoul、大韩民国、150-713
- St. Mary's Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patient who is between 18 and 60 years of age, inclusive
- Patient who is HBV DNA positive with DNA levels at screening more than 3 x 10^6 copies/mL.
Patient who is documented to be hepatitis B surface antigen (HBsAg) positive for > 6 months. Patient is HBeAg positive and anti-HBe negative.
Evidence of HBsAg (+) for the previous 6 months may include the following:
- documentation of HBsAg (+) for the previous 6 months
- documentation of HBsAg (+) for the previous 3 months and IgM anti-HBc negative at screening
- IgM anti-HBc negative and IgG anti-HBc positive at screening
- Patient who has ALT levels which are in the range of more than 2 to less than 10 times the upper limit of normal (x ULN) and bilirubin levels < 1.5 x ULN.
- Female patient with a negative serum (HCG) pregnancy test taken within 14 days of starting therapy.
- Patient who is able to give written informed consent prior to study start and to comply with the study requirements.
Patients who continue to meet the following criteria after completion of the Week 36 visit will have additional follow-up visits at Week 40, 44, 48:
- have received no additional therapy since completion of 12 weeks of treatment of L-FMAU and
- continue with period 1 log10 decrease in HBV DNA from baseline.
Exclusion Criteria:
- Patient who is currently receiving antiviral, immunomodulatory or corticosteroid therapy.
- Patients previously treated with lamivudine, lobucavir, adefovir or any other investigational nucleoside for HBV infection.
- Patients with previous treatment with interferon that have ended less than 6 months prior to the screening visit.
- Patient who has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
- Patient who is coinfected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV.
- Patient with clinical evidence of cirrhosis or hepatocellular carcinoma
- Patient who is pregnant or breast-feeding.
- Patient who is unwilling to use an "effective" method of contraception during the study and for up to 30 days 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., intrauterine device [IUD], barrier methods with spermicide or abstinence)
- Patient who has a clinically relevant history of abuse of alcohol or drugs.
- Patient who has a significant gastrointestinal, renal, hepatic (decompensated), bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease.
- Patient who has creatinine clearance less than 60 mL/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]
Patients found to have tyrosine, methionine, aspartate, aspartate (YMDD) HBV DNA polymerase mutation after the enrollment will be excluded from the efficacy evaluation but included in the safety evaluation.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
研究衡量的是什么?
主要结果指标
结果测量 |
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功效:HBV DNA 相对于基线的变化 (log10)
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次要结果测量
结果测量 |
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安全
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生命体征
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不良事件
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实验室测试
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Efficacy: Proportion of patients with HBV DNA below 1 pg/mL
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Proportion of patients with HBV DNA below the assay limit of detection (LOD) (SuperDigene HC test II LOD, <4,700 copies/mL)
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Proportion of patients with hepatitis Be antigen (HBeAg) loss
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Seroconversion rate (HBeAg loss and hepatitis Be antibody [HBeAb] positivity)
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Biochemical improvement (e.g., ALT normalization)
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Electrocardiogram (ECG)
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
研究完成
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
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