Back to resultsEfficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Domestic Tenofovir Disoproxil Fumarate Tablets
Tenofovir Disoproxil Fumarate Tablets of Gilead
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
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.
Sites / Locations
- Beijing Ditan Hospital Capital Medical UniversityRecruiting
- Peking University First HospitalRecruiting
- Peking University People's HospitalRecruiting
- Beijing You An Hospital, Capital Medical UniversityRecruiting
- First Affiliated Hospital, Third Military Medical UniversityRecruiting
- Third Affiliated Hospital of Sun Yat-senRecruiting
- Henan Provincial People's HospitalRecruiting
- First Affiliated Hospital of Zhengzhou UniversityRecruiting
- The Second Hospital of NanjingRecruiting
- First Affiliated Hospital of Nanjing Medical UniversityRecruiting
- Ruijin Hospital Shanghai Jiaotong University School of MedicineRecruiting
- Huashan Hospital, Fudan UniversityRecruiting
- Shanghai Public Health Clinical CenterRecruiting
- West China Hospital of Sichuan UniversityRecruiting
- First Affiliated Hospital of Zhejiang University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Domestic Tenofovir Disoproxil Fumarate Tablets
Tenofovir Disoproxil Fumarate Tablets of Gilead
Arm Description
Outcomes
Primary Outcome Measures
Compared with baseline, decline of serum HBV-DNA in the value
Secondary Outcome Measures
Full Information
NCT ID
NCT02287857
First Posted
October 30, 2014
Last Updated
March 16, 2019
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02287857
Brief Title
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
October 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis B
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
360 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Domestic Tenofovir Disoproxil Fumarate Tablets
Arm Type
Experimental
Arm Title
Tenofovir Disoproxil Fumarate Tablets of Gilead
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Domestic Tenofovir Disoproxil Fumarate Tablets
Intervention Description
1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead
Intervention Type
Drug
Intervention Name(s)
Tenofovir Disoproxil Fumarate Tablets of Gilead
Intervention Description
1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead
Primary Outcome Measure Information:
Title
Compared with baseline, decline of serum HBV-DNA in the value
Time Frame
48 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan yan Yu, doctor
Phone
13901194223
Email
yyy@bjnu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan yan Yu, doctor
Organizational Affiliation
Peking University First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hao Wang, doctor
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Chen, doctor
Organizational Affiliation
Beijing Ditan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xin yue Chen, doctor
Organizational Affiliation
Beijing You An Hospital, Capital Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wen hong Zhang, doctor
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qing Xie, doctor
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shan ming Wu, doctor
Organizational Affiliation
Shanghai Public Health Clinical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hong Tang, doctor
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qing Mao, doctor
Organizational Affiliation
First Affiliated Hospital, Third Military Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhi liang Gao, doctor
Organizational Affiliation
Third Affiliated Hospital of Sun Yat-sen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ji fang Shen, doctor
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jun Li, doctor
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wei Zhao, doctor
Organizational Affiliation
The Second Hospital of Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jia Shang, doctor
Organizational Affiliation
Henan Provincial People's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zu jiang Yu, doctor
Organizational Affiliation
The First Affiliated Hospital of Zhengzhou University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beijing Ditan Hospital Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100015
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao hua Hao, doctor
Phone
13466590802
Email
xiaohualuck@sina.com
Facility Name
Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li qin Yu, doctor
Phone
010-66119025
Email
jgbgs090101@126.com
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao Wang, doctor
Phone
010-88325988
Email
jgbgs090101@126.com
Facility Name
Beijing You An Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100069
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mei xia Wang, doctor
Phone
010-83997322
Email
youangcp@163.com
Facility Name
First Affiliated Hospital, Third Military Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong chuan Chen, doctor
Phone
13883405537
Email
zwmcyc@163.com
Facility Name
Third Affiliated Hospital of Sun Yat-sen
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510630
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Huang, doctor
Phone
02085253153
Email
sankyk@163.com
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiu Jin, doctor
Phone
13526660319
Facility Name
First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450052
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Li, doctor
Phone
13526506270
Facility Name
The Second Hospital of Nanjing
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Pan, doctor
Phone
13814099474
Facility Name
First Affiliated Hospital of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xu Huang, doctor
Phone
02568136360
Email
jsphkj@163.com
Facility Name
Ruijin Hospital Shanghai Jiaotong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi feng Wang, doctor
Phone
02154661789
Email
ruijin_gcp@126.com
Facility Name
Huashan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200040
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fei Dong, doctor
Phone
02152888041
Facility Name
Shanghai Public Health Clinical Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201508
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Na Li, doctor
Phone
18916082023
Email
lina40125@shaphc.org
Facility Name
West China Hospital of Sichuan University
City
Chengdou
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Liao, doctor
Phone
15828323384
Email
hxcrgcp@163.com
Facility Name
First Affiliated Hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li hua Wu, doctor
Phone
13819195192
12. IPD Sharing Statement
Citations:
PubMed Identifier
34222435
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.
Results Reference
derived
PubMed Identifier
31415381
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
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