A Single-Arm Study Evaluating the Efficacy of Liquid Acupuncture Therapeutics in Chronic Hepatitis B (CHB)

Inclusion Criteria:

• Male or female subjects aged 18-55 years inclusive.
• Documented chronic hepatitis B infection determined by the presence of serum HBsAg for at least 6 months.
• Serum HBV DNA ≥ 10^4 copies/mL(PRC).
• Use of interferon alfa, thymosin, or antiviral agents less than 1 year and not receive them more than 2 months. (If you expect to stop these agents but worry about the risk, you may ask us to help.)
• Agree not to participate in any other investigational trials or to undertake other HBV systemic antiviral regimens during participation in this study.
• Able to give written informed consent and comply with the requirements of the study.

Exclusion Criteria:

• Superinfection/Coinfection with hepatitis A, hepatitis C, hepatitis D, hepatitis E or HIV.
• Autoimmune hepatitis (antinuclear antibody titre > 1:160).
• Use of interferon alfa, thymosin, or antiviral agents more than 1 year.
• Pregnant or nursing.
• Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include, may not limit to, renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, active infection or cancer.
• Clinical signs of decompensated liver disease at baseline. These may include but are not limited to:serum bilirubin > 2.5 mg/dL (≤ 43 µmol/L), prothrombin time > 2 second prolonged above ULN,serum albumin < 35g/L,history of ascites, variceal bleeding, or encephalopathy,Alanine aminotransferase (ALT) >10 times ULN at screening or history of acute exacerbation leading to transient decompensation.

• Hepatocellular carcinoma as evidenced by one of the following:

  • suspicious foci on ultrasound or radiological examination.
  • where no positive ultrasound finding, but serum alpha-fetoprotein > 100ng/mL
  • Active alcohol or drug abuse or history of alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
• Received hepatotoxic drugs (e.g., anabolic steroids, ketaconazole, itraconazole, isoniazid, rifampin, rifabutin) within 2 months prior to study screening or expected to receive these during the course of the study.
• Received nephrotoxic drugs (e.g., aminoglycosides, amphotericin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that patient will receive any of these during the course of the study.
• Receiving systemic (intravenous or oral) steroids, immuno-suppressant therapies or chemotherapeutic agents within 2 months of study screening or expected to receive these agents during the course of the study.
• Neutrophile granulocyte count <1.0*10e9/L and Platelet count < 30*10e9/L.
• Inability to comply with study requirements.