Back to resultsEfficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
Primary Purpose
Chronic Hepatitis B
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Entecavir maleate tablets
blank Baraclude tablets
Blank maleate entecavir tablets
Baraclude tablets
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hepatitis B
Eligibility Criteria
Inclusion Criteria:
- Subjects diagnosed of HBeAg positive or negative chronic hepatitis B
- Aged 18 to 70 years old，male or female
- Patients with previously HBsAg-positive, HBeAg-positive for 24 weeks, HBV-DNA> 105copies/ml. HBeAg-negative for 24 weeks or more, HBV-DNA> 105 copies/ml.
- 1.3 times the upper normal limit (1.3 × 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 ≥ 70 × 109 / L, serum albumin (ALB)≥ 35 g / L.
- Creatinine (Cr) ≤ 1.5 × ULN.
- If patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
- Patients signed an informed consent form and compliance was good.
Exclusion Criteria:
- Patients were infected with other viruses as HAV, HCV, HDV, HEV, CMV, EBV, HIV etc.
- Patients with cirrhosis or liver cancer.
- Patients have participated in another therapeutic clinical trial in 3 months.
- Granulocyte count <1.5 × 109 / L, hemoglobin (HB)<100g / L, sera alpha-fetoprotein(AFP)> 100μg / L, patients' B ultrasonography pointed space-occupying lesions.
- Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
- Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
- Pregnant woman, lactating women or those who wre allergic for study drug.
Sites / Locations
- Department of Infectious Diseases,Peking University First Hospital
- Beijing You An Hospital,Capital Medical University
- The First Affiliated Hospital Of The Third Mililary Medical University
- Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology
- The First Affiliated Hospital Of Nanjing Medical University
- Shanghai Jiaotong University Affiliated Ruijin Hospital
- The Second Affiliated Hospital Of Chongqing Medical University
- West China Hospital Of Sichuan University
- The First Affiliated Hospital Of Zhejiang University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
HBeAg positive group
HBeAg-negative group
Arm Description
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks . Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Outcomes
Primary Outcome Measures
Compared with baseline, decline of serum HBV-DNA in the value
Secondary Outcome Measures
Full Information
NCT ID
NCT01926288
First Posted
August 13, 2013
Last Updated
December 27, 2017
Sponsor
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01926288
Brief Title
Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
Official Title
Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
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 Entecavir maleate tablets in Chinese patients with hepatitis B
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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
287 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HBeAg positive group
Arm Type
Other
Arm Description
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Arm Title
HBeAg-negative group
Arm Type
Other
Arm Description
Entecavir maleate tablets (1) + blank Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Blank maleate entecavir tablets (1) + Baraclude tablets (1),once a day Empty stomach (at least 2 hours after a meal or fasting), treatment for 48 weeks, then enter the open-label trial extended to 240 weeks .
Intervention Type
Drug
Intervention Name(s)
Entecavir maleate tablets
Intervention Type
Drug
Intervention Name(s)
blank Baraclude tablets
Intervention Type
Drug
Intervention Name(s)
Blank maleate entecavir tablets
Intervention Type
Drug
Intervention Name(s)
Baraclude tablets
Primary Outcome Measure Information:
Title
Compared with baseline, decline of serum HBV-DNA in the value
Time Frame
5 years
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:
Subjects diagnosed of HBeAg positive or negative chronic hepatitis B
Aged 18 to 70 years old，male or female
Patients with previously HBsAg-positive, HBeAg-positive for 24 weeks, HBV-DNA> 105copies/ml. HBeAg-negative for 24 weeks or more, HBV-DNA> 105 copies/ml.
1.3 times the upper normal limit (1.3 × 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 ≥ 70 × 109 / L, serum albumin (ALB)≥ 35 g / L.
Creatinine (Cr) ≤ 1.5 × ULN.
If patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
Patients signed an informed consent form and compliance was good.
Exclusion Criteria:
Patients were infected with other viruses as HAV, HCV, HDV, HEV, CMV, EBV, HIV etc.
Patients with cirrhosis or liver cancer.
Patients have participated in another therapeutic clinical trial in 3 months.
Granulocyte count <1.5 × 109 / L, hemoglobin (HB)<100g / L, sera alpha-fetoprotein(AFP)> 100μg / L, patients' B ultrasonography pointed space-occupying lesions.
Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
Pregnant woman, lactating women or those who wre allergic for study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Yan yan, doctor
Organizational Affiliation
Department of Infectious Diseases,Peking University First Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Shi Guang feng, doctor
Organizational Affiliation
Huashan Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Xie Qing, doctor
Organizational Affiliation
Shanghai Jiaotong University Affiliated Ruijin Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tang Hong, doctor
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Zhang Da zhi, doctor
Organizational Affiliation
The Second Affiliated Hospital of Chongqing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mao Qing, doctor
Organizational Affiliation
The First Affiliated Hospital Of The Third Mililary Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ning Qin, doctor
Organizational Affiliation
Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li Jun, doctor
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sheng Ji fang, doctor
Organizational Affiliation
Zhejiang University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheng Xin fang, doctor
Organizational Affiliation
Beijing You An Hospital,Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Infectious Diseases,Peking University First Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100034
Country
China
Facility Name
Beijing You An Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100054
Country
China
Facility Name
The First Affiliated Hospital Of The Third Mililary Medical University
City
Chongqing
State/Province
Chongqing
ZIP/Postal Code
400038
Country
China
Facility Name
Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Facility Name
The First Affiliated Hospital Of Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Shanghai Jiaotong University Affiliated Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
The Second Affiliated Hospital Of Chongqing Medical University
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
400010
Country
China
Facility Name
West China Hospital Of Sichuan University
City
Chongqing
State/Province
Sichuan
ZIP/Postal Code
400010
Country
China
Facility Name
The First Affiliated Hospital Of Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
36246814
Citation
Xu JH, Wang S, Zhang DZ, Yu YY, Si CW, Zeng Z, Xu ZN, Li J, Mao Q, Tang H, Sheng JF, Chen XY, Ning Q, Shi GF, Xie Q, Zhang XQ, Dai J. One hundred and ninety-two weeks treatment of entecavir maleate for Chinese chronic hepatitis B predominantly genotyped B or C. World J Clin Cases. 2022 Oct 6;10(28):10085-10096. doi: 10.12998/wjcc.v10.i28.10085.
Results Reference
derived
PubMed Identifier
28345157
Citation
Xu JH, Wang S, Xu ZN, Yu YY, Si CW, Zeng Z, Li J, Mao Q, Zhang DZ, Tang H, Sheng JF, Chen XY, Ning Q, Shi GF, Xie Q, Zhang XQ, Dai J. Entecavir maleate versus entecavir in Chinese chronic hepatitis B predominantly genotype B or C: Results at week 144. J Viral Hepat. 2017 Oct;24(10):877-884. doi: 10.1111/jvh.12710. Epub 2017 Aug 11.
Results Reference
derived
PubMed Identifier
26604649
Citation
Li N, Xu JH, Yu M, Wang S, Si CW, Yu YY. Relationship between virological response and FIB-4 index in chronic hepatitis B patients with entecavir therapy. World J Gastroenterol. 2015 Nov 21;21(43):12421-9. doi: 10.3748/wjg.v21.i43.12421.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
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