Phase
Condition
Liver Disorders
Diabetes And Hypertension
Circulation Disorders
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
More than 6 months history of serum positive HBsAg
Abdominal ultrasonogram or CT scan or liver-biopsy specimen indicates liver cirrhosis
Age 18-65
Child-Pugh<7 (Stage A)
Without portal hypertension(Endoscopy indicates no signs of gastroesophageal varices.)
Low-grade of portal hypertension(Endoscopy indicates signs of gastroesophageal varicesthat is line shape without red wales or spots and less than 0.3cm of diameter.)
The patient or the patient's guardian agrees to participate the random controlledtrial and sign the Informed Consent Form.
Exclusion
Exclusion Criteria:
Primary Lamivudine, Adefovir dipivoxil and Entecavir resistance
Decompensated cirrhosis、The Child-Pugh score≥7
Moderate grade of portal hypertension(Endoscopy indicates signs of gastroesophagealvarices that is line shape with red wales or spots and less than 0.3cm of diameter,orsnake large shape without red wales or spots and less than 1.0cm of diameter.)
Severe grade of portal hypertension(Endoscopy indicates signs of gastroesophagealvarices that is catenulate/nodular shape with or without red wales or spots and morethan 1.0cm of diameter.)
Decompensated liver cirrhosis Liver cancer
Liver histology conform to other chronic liver disease cause (exclude fatty liver)
Non-HBV avihepadnavirus infected acute and chronic hepatitis, autoimmune hepatitis,primary biliary cirrhosis, primary sclerosing cholangitis, inherited metabolic liverdisease, drug or toxic hepatitis, Alcoholic liver disease.
Have psychiatric history or uncontrollable epilepsy patient.
Uncontrollable diabetic patient
History of Hemoglobin disease (such as Alpha globin generation barrier anemia, Sicklecell deficiency, Spherocytosis) or Hemolytic anemia patients caused by other reasonslike autoimmunity.
Severe background disease like chronic respiratory failure, circulatory failure,kidney failure etc.
In situ organ transplantation (such as liver, kidney, lung and heart) or bone marrowtransplantation and stem cell transplantation.
Immunocompromised patients: such as HIV infection or take immunosuppressor orglucocorticoid (such as cyclosporin, azathioprine, adrenocortical hormone) within 3months or chemotherapy drugs (such as cyclophosphamide, ammonia and cancerchemotherapy) and radioactive therapy.
Gestation or lactation period women and women who plan to get pregnant during thestudy period.
Patient who are allergy to the experimental drug.
Using history of anti-viral or anti-fibrosis drug within 6 months.
Patients who are participating other trials.
Other situation where PI thinks the patient should be excluded.
Study Design
Study Description
Connect with a study center
Ruijin Hospital
Shanghai,
ChinaActive - Recruiting
Shanghai Zhongshan Hospital
Shanghai,
ChinaActive - Recruiting
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Shanghai,
ChinaActive - Recruiting
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