Clinical trial NCT02287857: Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Hepatitis B
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-11-11
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Compared with baseline, decline of serum HBV-DNA in the value
timeFrame: 48 week
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Ditan Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing You An Hospital, Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: First Affiliated Hospital, Third Military Medical University
state: Chongqing
city: Guangzhou
country: China
facility: Third Affiliated Hospital of Sun Yat-sen
state: Guangdong
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: First Affiliated Hospital of Zhengzhou University
state: Henan
city: Nanjing
country: China
facility: The Second Hospital of Nanjing
state: Jiangsu
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
city: Shanghai
country: China
facility: Ruijin Hospital Shanghai Jiaotong University School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital, Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Public Health Clinical Center
state: Shanghai
city: Chengdou
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Peking University First Hospital
name: Yan yan Yu, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University People's Hospital
name: Hao Wang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing Ditan Hospital
name: Jun Chen, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing You An Hospital, Capital Medical University
name: Xin yue Chen, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Wen hong Zhang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Ruijin Hospital
name: Qing Xie, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Public Health Clinical Center
name: Shan ming Wu, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Hong Tang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital, Third Military Medical University
name: Qing Mao, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Third Affiliated Hospital of Sun Yat-sen
name: Zhi liang Gao, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University
name: Ji fang Shen, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jun Li, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Hospital of Nanjing Medical University
name: Wei Zhao, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Henan Provincial People's Hospital
name: Jia Shang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Zu jiang Yu, doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chen XF, Fan YN, Si CW, Yu YY, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Xu JH. Tenofovir disoproxil fumarate in Chinese chronic hepatitis B patients: Results of a multicenter, double-blind, double-dummy, clinical trial at 96 weeks. World J Clin Cases. 2021 Jun 26;9(18):4690-4699. doi: 10.12998/wjcc.v9.i18.4690.
citation: Liang RY, Xu JH, Si CW, Wang S, Shang J, Yu ZJ, Mao Q, Xie Q, Zhao W, Li J, Gao ZL, Wu SM, Tang H, Cheng J, Chen XY, Zhang WH, Wang H, Xu ZN, Wang L, Dai J, Yu YY. A randomized, double-blind, double-dummy, controlled, multicenter study of Qingzhong (tenofovir disoproxil fumarate) versus Viread for the treatment of chronic hepatitis B: First-stage results at week 48. Medicine (Baltimore). 2019 Aug;98(33):e16778. doi: 10.1097/MD.0000000000016778.