The Safety and Dose-range Study of Metacavir Enteric-coated Capsules in Patients With Chronic Hepatitis B

This is an interventional treatment trial for Chronic Hepatitis B focused on measuring Chronic Hepatitis B Read More

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.