Phase
Condition
Hepatitis
Liver Disorders
Hepatitis B
Treatment
N/AClinical Study ID
Ages 18-60 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
More than 6 months history of serum positive HBsAg
Positive HBV-DNA
Age 18-60
Ishak fibrosis score of the biopsy within 6 months ≥5, no anti-virus or anti-fibrosisdrug was taken within 6 months.
Child-Pugh<7 (Stage A)
The patient or the patient's guardian agrees to participate the trial and sign theinformed Consent Form.
Exclusion
Exclusion Criteria:
Primary Lamivudine, Adefovir dipivoxil and Entecavir resistance
Decompensated liver cirrhosis
HCC
Liver histology conforming to other chronic liver diseases, such as moderate or severenon-alcoholic fatty liver disease(more than 1/3 steatosis in liver ), chronichepatitis C, chronic hepatitis D, autoimmune hepatitis, primary biliary cholangitis,primary sclerosing cholangitis, inherited metabolic liver disease, drug or toxicinduced liver injury, parasitic infections, alcoholic liver disease.
Have psychiatric history or uncontrollable epilepsy patient.
Uncontrollable diabetic patient
History of hemoglobin disease (such as alpha- or beta-thalassemia, sickle celldisease, spherocytosis) or patients with toxic or autoimmune hemolytic anemia.
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
Connect with a study center
Guangxi Ruikang Hospital
Nanning, Guangxi
ChinaActive - Recruiting
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei
ChinaActive - Recruiting
The Fifth People's Hospital of Anyang
Anyang, Henan
ChinaActive - Recruiting
Jingmen No.1 People's Hospital
Jingmen, Hubei
ChinaActive - Recruiting
Hubei Hospital of TCM
Wuhan, Hubei
ChinaActive - Recruiting
Tongji Hospital
Wuhan, Hubei
ChinaActive - Recruiting
The First Affiliated Hospital of Hunan University of TCM
Changsha, Hunan
ChinaActive - Recruiting
Huai'an No. 4 People's Hospital
Huai'an, Jiangsu
ChinaActive - Recruiting
The Fifth People's Hospital of Suzhou
Suzhou, Jiangsu
ChinaActive - Recruiting
The Ninth Hospital of Nanchang
Nanchang, Jiangxi
ChinaActive - Recruiting
Ningxia People's Hospital
Yinchuan, Ningxia
ChinaActive - Recruiting
Affiliated Hospital of Shandong Univercity of TCM
Jinan, Shandong
ChinaActive - Recruiting
Wenzhou Central Hospital
Wenzhou, Zhejiang
ChinaActive - Recruiting
Beijing Ditan Hospital Capital Medical University
Beijing,
ChinaActive - Recruiting
Beijing Youan Hospital Capital Medical University
Beijing,
ChinaActive - Recruiting
China-Japan Friendship Hospital
Beijing,
ChinaActive - Recruiting
Ruijin Hospital
Shanghai,
ChinaActive - Recruiting
Shanghai Zhongshan Hospital
Shanghai,
ChinaActive - Recruiting
ShuGuang Hospital
Shanghai, 201203
ChinaActive - Recruiting
Shenzhen Third People's Hospital
Shenzhen,
ChinaActive - Recruiting

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