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临床试验/NCT02965859
NCT02965859Unknown2 期

A Randomized,Double-blind,Double-dummy,Multiple-dose Parallel Control,Multiple Centers Study to Assess the Safety and Dose-range of Metacavir Enteric-coated Capsules for Patients With Chronic Hepatitis B

Guangzhou Yipinhong Pharmaceutical CO.,LTD1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2012年12月最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
2 期
入组人数
180
试验地点
1
主要终点
The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study objective is to evaluate the safety and effectiveness of different doses of Metacavir Enteric-coated Capsules in treatment of chronic hepatitis B,as well as to find an appropriate clinical dosage by comparing the effect of different doses of treatment,in order to provide references of clinical trial of the next phase.

详细描述

180 eligible subjects will be included.According to the set grouping method of dose escalation.Subjects will be randomized in a 1:1:1:1 proportion of Metacavir Enteric-coated Capsules(80mg/160mg/320mg) group,positive control group or placebo control group.Each group has 36 subjects.

1.Subjects will use the study medication(2 hours before or after meal,once a day) from Visit 3 to Visit 5.

  1. Metacavir Enteric-coated Capsules 80mg Group:Metacavir Enteric-coated Capsules 80mg,Metacavir Enteric-coated Capsules Placebo 240mg,Adefovir Dipivoxil Capsule Placebo 10mg;
  2. Metacavir Enteric-coated Capsules 160mg Group:Metacavir Enteric-coated Capsules 160mg,Metacavir Enteric-coated Capsules Placebo 160mg,Adefovir Dipivoxil Capsule Placebo 10mg;
  3. Metacavir Enteric-coated Capsules 320mg Group:Metacavir Enteric-coated Capsules 320mg,Adefovir Dipivoxil Capsule Placebo 10mg;
  4. Positive Control(Adefovir Dipivoxil Capsule) Group:Metacavir Enteric-coated Capsules Placebo 320mg,Adefovir Dipivoxil Capsule 10mg;
  5. Placebo Control Group:Metacavir Enteric-coated Capsules Placebo 320mg,Adefovir Dipivoxil Capsule Placebo 10mg;

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 (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Are at least 18 years of age and no older than 65;
  • •Subjects,with an established clinical history of HBV at Screening,has a positive HBsAg test(>6months) regardless of a positive/negative HBeAg test;
  • •At Screening,HBV-DNA>10^5 copies/ml in HBeAg positive or HBV-DNA>10^4 copies/ml in HBeAg negative(HBV-DNA was evaluated by polymerase chain reaction fluorescent labeling.);
  • •Subjects with abnormal liver function test defined as alanine aminotransferase(ALT) was 2~10 times upper limit of normal in HBeAg positive or 1.5~10 times upper limit of normal in HBeAg negative;
  • •Subjects who are willing to require any other treatment for anti-hepatitis B during the study period;
  • •Subjects who are willing to take measures for effective non-pharmaceutical contraception;
  • •Given their signed written informed consent to participate;

排除标准

  • •Subjects with hepatitis C(HCV),hepatitis D(HDV),autoimmune hepatitis,hereditary liver disease or any other active hepatitis;
  • •A positive human immunodeficiency virus(HIV) test result;
  • •Subjects,who in the opinion of the investigator,have a current diagnosis of hepatocellular carcinoma or serum α-fetoprotein(AFP)>100ug/L;
  • •Subjects with severe hepatitis or decompensated liver disease defined as hepatic encephalopathy,ascites,low protein blood syndrome(albumin ≤30g/l) or variceal bleeding;
  • •Serum Creatinine(SCr) exceeds upper limit of normal;
  • •At Screening,ALT>10 times upper limit of normal,Total Bilirubin(TBIL)>double upper limit of normal or transient hepatic decompensation caused by condition aggravation;
  • •Subjects who required treatment with nucleoside antiviral drugs such as lamivudine,Adefovir dipivoxil,Telbivudine,Tenofovir disoproxil or Entecavir before Screening;
  • •Subjects who require treatment with interferon-α，thymosin α-1 or other antiviral therapy,immunosuppressive agents,immune modulators within 6 months before Screening;
  • •Subjects with cardiac disease,hematological system disease,cancer,impaired immunity or psychiatric disease;
  • •Hemoglobin<10g/dl,white blood cell count<3.5 10^9/L,platelets<80 10^9/L;
  • •Subjects,who in the opinion of the investigator,have a current diagnosis of pancreatitis pre-dose within 24 weeks;
  • •History of hypersensitivity or allergy to any of the study drugs;
  • •Subjects who participate in other clinical trials within 3 months prior to Screening;
  • •Women who are pregnant or lactating or planning a pregnancy recently;
  • •Subjects in the opinion of the investigator,could not participate in the study.

研究组 & 干预措施

Metacavir Enteric-coated Capsule 80mg

Experimental
  1. Metacavir Enteric-coated Capsules 80mg
  2. Metacavir Enteric-coated Capsules Placebo 240mg
  3. Adefovir Dipivoxil Capsule Placebo 10mg;

干预措施: Metacavir Enteric-coated Capsules 80mg (Drug)

Metacavir Enteric-coated Capsule 80mg

Experimental
  1. Metacavir Enteric-coated Capsules 80mg
  2. Metacavir Enteric-coated Capsules Placebo 240mg
  3. Adefovir Dipivoxil Capsule Placebo 10mg;

干预措施: Metacavir Enteric-coated Capsules Placebo 240mg (Drug)

Metacavir Enteric-coated Capsule 80mg

Experimental
  1. Metacavir Enteric-coated Capsules 80mg
  2. Metacavir Enteric-coated Capsules Placebo 240mg
  3. Adefovir Dipivoxil Capsule Placebo 10mg;

干预措施: Adefovir Dipivoxil Capsule Placebo 10mg (Drug)

Metacavir Enteric-coated Capsules 160mg

Active Comparator
  1. Metacavir Enteric-coated Capsules 160mg
  2. Metacavir Enteric-coated Capsules Placebo 160mg
  3. Adefovir Dipivoxil Capsule Placebo 10mg;

干预措施: Metacavir Enteric-coated Capsules 160mg (Drug)

Metacavir Enteric-coated Capsules 160mg

Active Comparator
  1. Metacavir Enteric-coated Capsules 160mg
  2. Metacavir Enteric-coated Capsules Placebo 160mg
  3. Adefovir Dipivoxil Capsule Placebo 10mg;

干预措施: Metacavir Enteric-coated Capsules Placebo 160mg (Drug)

Metacavir Enteric-coated Capsules 160mg

Active Comparator
  1. Metacavir Enteric-coated Capsules 160mg
  2. Metacavir Enteric-coated Capsules Placebo 160mg
  3. Adefovir Dipivoxil Capsule Placebo 10mg;

干预措施: Adefovir Dipivoxil Capsule Placebo 10mg (Drug)

Metacavir Enteric-coated Capsules 320mg

Placebo Comparator
  1. Metacavir Enteric-coated Capsules 320mg
  2. Adefovir Dipivoxil Capsule Placebo 10mg

干预措施: Metacavir Enteric-coated Capsules 320mg (Drug)

Metacavir Enteric-coated Capsules 320mg

Placebo Comparator
  1. Metacavir Enteric-coated Capsules 320mg
  2. Adefovir Dipivoxil Capsule Placebo 10mg

干预措施: Adefovir Dipivoxil Capsule Placebo 10mg (Drug)

Adefovir Dipivoxil Capsule

Active Comparator
  1. Metacavir Enteric-coated Capsules Placebo 320mg
  2. Adefovir Dipivoxil Capsule 10mg;

干预措施: Metacavir Enteric-coated Capsules Placebo 320mg (Drug)

Adefovir Dipivoxil Capsule

Active Comparator
  1. Metacavir Enteric-coated Capsules Placebo 320mg
  2. Adefovir Dipivoxil Capsule 10mg;

干预措施: Adefovir Dipivoxil Capsule10mg (Drug)

Placebo

Placebo Comparator
  1. Metacavir Enteric-coated Capsules Placebo 320mg
  2. Adefovir Dipivoxil Capsule Placebo 10mg;

干预措施: Metacavir Enteric-coated Capsules 320mg (Drug)

Placebo

Placebo Comparator
  1. Metacavir Enteric-coated Capsules Placebo 320mg
  2. Adefovir Dipivoxil Capsule Placebo 10mg;

干预措施: Metacavir Enteric-coated Capsules Placebo 320mg (Drug)

Placebo

Placebo Comparator
  1. Metacavir Enteric-coated Capsules Placebo 320mg
  2. Adefovir Dipivoxil Capsule Placebo 10mg;

干预措施: Adefovir Dipivoxil Capsule Placebo 10mg (Drug)

结局指标

主要结局

The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.

时间窗: 12 weeks

The change from baseline in the logarithms of measurement data of HBV-DNA at Week 12 of treatment.（Unit：log10)

次要结局

  • Incidence of Adverse Events(AEs)(48 weeks)
  • Incidence of treatment-chronic hepatitis B(12 weeks)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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