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

Not Applicable

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Tenofovir Disoproxil Fumarate Tablets of Gilead; Drug: Domestic Tenofovir Disoproxil Fumarate Tablets

• Registration Number: NCT02287857
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

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 Tablets of Gilead.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-30
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-11
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-16
• Last Update Posted: 2019-03-19
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tenofovir Disoproxil Fumarate Tablets of Gilead	Tenofovir Disoproxil Fumarate Tablets of Gilead	-
Domestic Tenofovir Disoproxil Fumarate Tablets	Domestic Tenofovir Disoproxil Fumarate Tablets	-

Primary Outcome Measures

Name	Time	Method
Compared with baseline, decline of serum HBV-DNA in the value	48 week

Trial Locations

Locations (15)

Ruijin Hospital Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China

First Affiliated Hospital of Zhengzhou University; 🇨🇳 Zhengzhou, Henan, China

Beijing Ditan Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing You An Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Third Affiliated Hospital of Sun Yat-sen; 🇨🇳 Guangzhou, Guangdong, China

First Affiliated Hospital, Third Military Medical University; 🇨🇳 Chongqing, Chongqing, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

The Second Hospital of Nanjing; 🇨🇳 Nanjing, Jiangsu, China

First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

Huashan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China

Shanghai Public Health Clinical Center; 🇨🇳 Shanghai, Shanghai, China

West China Hospital of Sichuan University; 🇨🇳 Chengdou, Sichuan, China

First Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Peking University First Hospital; 🇨🇳 Beijing, Beijing, China