Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B

• Status: Unknown status
• Trial end date: 2019-10-01
• Target enrollment: 0
• Participant gender: All

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 Tablets of Gilead.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Treatments: Tenofovir

Criteria

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.