Chronic Hepatitis B Clinical Trial
The purpose of this study is to evaluate the safety and efficacy of Domestic Tenofovir Disoproxil Fumarate Tablets in Chinese patients with hepatitis B ,compared with Tenofovir Disoproxil Fumarate Tablets of Gilead.
Status | Recruiting |
Enrollment | 360 |
Est. completion date | October 2019 |
Est. primary completion date | October 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - The initial treatment of subjects diagnosed of HBeAg positive or negative chronic hepatitis B - Aged 18 to 65 years old,male or female - Patients with previously HBsAg-positive lasted for 6months at least:HBeAg-positive subjects, HBV-DNA> 105copies/ml; HBeAg-negative subjects, HBV-DNA> 104copies/ml. - 2 times the upper normal limit (2 × ULN) = alanine aminotransferase (ALT) = 10 × ULN. - Total serum bilirubin (TBIL) = 2.5 × ULN. - Prothrombin activity (PTA) = 60% or prothrombin time prolonged than normal = 3 seconds). - WBC = 3.5 × 109 / L, PLT = 80 × 109 / L, serum albumin (ALB)= 35 g / L. - Creatinine (Cr) = 1× ULN,serum phosphate was normal. - Patients signed an informed consent form and compliance was good. Exclusion Criteria: - Patients were infected with other viruses as HAV, HCV, HEV, HIV etc. - Patients with cirrhosis or liver cancer. - Pregnant woman, lactating women . - Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases. - Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus. - Patients allergic for study drug. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Ditan Hospital Capital Medical University | Beijing | Beijing |
China | Beijing You An Hospital, Capital Medical University | Beijing | Beijing |
China | Peking University First Hospital | Beijing | Beijing |
China | Peking University People's Hospital | Beijing | Beijing |
China | West China Hospital of Sichuan University | Chengdou | Sichuan |
China | First Affiliated Hospital, Third Military Medical University | Chongqing | Chongqing |
China | Third Affiliated Hospital of Sun Yat-sen | Guangzhou | Guangdong |
China | First Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | Zhejiang |
China | First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu |
China | The Second Hospital of Nanjing | Nanjing | Jiangsu |
China | Huashan Hospital, Fudan University | Shanghai | Shanghai |
China | Ruijin Hospital Shanghai Jiaotong University School of Medicine | Shanghai | Shanghai |
China | Shanghai Public Health Clinical Center | Shanghai | Shanghai |
China | First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan |
China | Henan Provincial People's Hospital | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Compared with baseline, decline of serum HBV-DNA in the value | 48 week |
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