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

CTTQ

Status

Unknown

Conditions

Chronic Hepatitis B

Treatments

Drug: Tenofovir Disoproxil Fumarate Tablets of Gilead

Drug: Domestic Tenofovir Disoproxil Fumarate Tablets

Study type

Interventional

Funder types

Industry

Identifiers

NCT02287857

CTTQ-TDF-V4.0

Details and patient eligibility

About

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.

Enrollment

360 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.