Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
NCT ID: NCT01926288
Last Updated: 2017-12-29
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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COMPLETED
PHASE4
287 participants
INTERVENTIONAL
2008-10-31
2014-03-31
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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HBeAg positive group
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
blank Baraclude tablets
Blank maleate entecavir tablets
Baraclude tablets
HBeAg-negative group
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
blank Baraclude tablets
Blank maleate entecavir tablets
Baraclude tablets
Interventions
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Entecavir maleate tablets
blank Baraclude tablets
Blank maleate entecavir tablets
Baraclude tablets
Eligibility Criteria
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Inclusion Criteria
2. Aged 18 to 70 years old，male or female
3. 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.
4. 1.3 times the upper normal limit (1.3 × ULN) ≤ alanine aminotransferase (ALT) ≤ 10 × ULN.
5. Total serum bilirubin (TBIL) ≤ 2.5 × ULN.
6. Prothrombin activity (PTA) ≥ 60% or prothrombin time prolonged than normal ≤ 3 seconds).
7. WBC ≥ 3.5 × 109 / L, PLT ≥ 70 × 109 / L, serum albumin (ALB)≥ 35 g / L.
8. Creatinine (Cr) ≤ 1.5 × ULN.
9. If patients take intermittently with interferon, nucleoside (acid) analogues, α1 thymosin before enrollment with 24 weeks, the time is no more than 12 weeks.
10. Patients signed an informed consent form and compliance was good.
Exclusion Criteria
2. Patients with cirrhosis or liver cancer.
3. Patients have participated in another therapeutic clinical trial in 3 months.
4. Granulocyte count \<1.5 × 109 / L, hemoglobin (HB)\<100g / L, sera alpha-fetoprotein(AFP)\> 100μg / L, patients' B ultrasonography pointed space-occupying lesions.
5. Patients with severe heart, kidney, endocrine hematopoietic system and neuropsychiatric diseases.
6. Patients with metabolic or autoimmune diseases such as systemic lupus erythematosus.
7. Pregnant woman, lactating women or those who wre 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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Yu Yan yan, doctor
Role: PRINCIPAL_INVESTIGATOR
Department of Infectious Diseases,Peking University First Hospital
Shi Guang feng, doctor
Role: PRINCIPAL_INVESTIGATOR
Huashan Hospital
Xie Qing, doctor
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiaotong University Affiliated Ruijin Hospital
Tang Hong, doctor
Role: PRINCIPAL_INVESTIGATOR
West China Hospital
Zhang Da zhi, doctor
Role: PRINCIPAL_INVESTIGATOR
The Second Affiliated Hospital of Chongqing Medical University
Mao Qing, doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital Of The Third Mililary Medical University
Ning Qin, doctor
Role: PRINCIPAL_INVESTIGATOR
Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology
Li Jun, doctor
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital with Nanjing Medical University
Sheng Ji fang, doctor
Role: PRINCIPAL_INVESTIGATOR
Zhejiang University
Cheng Xin fang, doctor
Role: PRINCIPAL_INVESTIGATOR
Beijing You An Hospital,Capital Medical University
Locations
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Department of Infectious Diseases,Peking University First Hospital
Beijing, Beijing Municipality, China
Beijing You An Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The First Affiliated Hospital Of The Third Mililary Medical University
Chongqing, Chongqing Municipality, China
Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology
Wuhan, Hubei, China
The First Affiliated Hospital Of Nanjing Medical University
Nanjing, Jiangsu, China
Shanghai Jiaotong University Affiliated Ruijin Hospital
Shanghai, Shanghai Municipality, China
The Second Affiliated Hospital Of Chongqing Medical University
Chongqing, Sichuan, China
West China Hospital Of Sichuan University
Chongqing, Sichuan, China
The First Affiliated Hospital Of Zhejiang University
Hangzhou, Zhejiang, China
Countries
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References
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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.
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.
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.
Other Identifiers
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CTTQ805-4
Identifier Type: -
Identifier Source: org_study_id