Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
NCT ID: NCT02287857
Last Updated: 2019-03-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
360 participants
INTERVENTIONAL
2014-09-30
2019-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Domestic Tenofovir Disoproxil Fumarate Tablets
Domestic Tenofovir Disoproxil Fumarate Tablets
1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead
Tenofovir Disoproxil Fumarate Tablets of Gilead
Tenofovir Disoproxil Fumarate Tablets of Gilead
1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead
Interventions
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Domestic Tenofovir Disoproxil Fumarate Tablets
1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead
Tenofovir Disoproxil Fumarate Tablets of Gilead
1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
65 Years
ALL
No
Sponsors
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Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yan yan Yu, doctor
Role: PRINCIPAL_INVESTIGATOR
Peking University First Hospital
Hao Wang, doctor
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Jun Chen, doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing Ditan Hospital
Xin yue Chen, doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing You An Hospital, Capital Medical University
Wen hong Zhang, doctor
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Qing Xie, doctor
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Shan ming Wu, doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Public Health Clinical Center
Hong Tang, doctor
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Qing Mao, doctor
Role: PRINCIPAL_INVESTIGATOR
First Affiliated Hospital, Third Military Medical University
Zhi liang Gao, doctor
Role: PRINCIPAL_INVESTIGATOR
Third Affiliated Hospital of Sun Yat-sen
Ji fang Shen, doctor
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University
Jun Li, doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Wei Zhao, doctor
Role: PRINCIPAL_INVESTIGATOR
The Second Hospital of Nanjing Medical University
Jia Shang, doctor
Role: PRINCIPAL_INVESTIGATOR
Henan Provincial People's Hospital
Zu jiang Yu, doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Zhengzhou University
Locations
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Beijing Ditan Hospital Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing, Beijing Municipality, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Beijing You An Hospital, Capital Medical University
Beijing, Beijing Municipality, China
First Affiliated Hospital, Third Military Medical University
Chongqing, Chongqing Municipality, China
Third Affiliated Hospital of Sun Yat-sen
Guangzhou, Guangdong, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
The Second Hospital of Nanjing
Nanjing, Jiangsu, China
First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
Shanghai Public Health Clinical Center
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdou, Sichuan, China
First Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Xiu Jin, doctor
Role: primary
Juan Li, doctor
Role: primary
Yu Pan, doctor
Role: primary
Fei Dong, doctor
Role: primary
Li hua Wu, doctor
Role: primary
References
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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.
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.
Other Identifiers
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CTTQ-TDF-V4.0
Identifier Type: -
Identifier Source: org_study_id
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