Status:
UNKNOWN
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Conditions:
Chronic Hepatitis B
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 Tab...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2019
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT02287857
Start Date
September 1 2014
End Date
October 1 2019
Last Update
March 19 2019
Active Locations (15)
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1
Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100015
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
3
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044
4
Beijing You An Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100069