Clinical trial NCT01926288: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Hepatitis B
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-08-20
Enrollment: 287
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 Entecavir maleate tablets in Chinese patients with hepatitis B


Eligibility criteria: Inclusion Criteria:

1. Subjects diagnosed of HBeAg positive or negative chronic hepatitis B
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:

1. Patients were infected with other viruses as HAV, HCV, HDV, HEV, CMV, EBV, HIV etc.
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.

Primary outcomes:
measure: Compared with baseline, decline of serum HBV-DNA in the value
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of Infectious Diseases,Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing You An Hospital,Capital Medical University
state: Beijing
city: Chongqing
country: China
facility: The First Affiliated Hospital Of The Third Mililary Medical University
state: Chongqing
city: Wuhan
country: China
facility: Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology
state: Hubei
city: Nanjing
country: China
facility: The First Affiliated Hospital Of Nanjing Medical University
state: Jiangsu
city: Shanghai
country: China
facility: Shanghai Jiaotong University Affiliated Ruijin Hospital
state: Shanghai
city: Chongqing
country: China
facility: The Second Affiliated Hospital Of Chongqing Medical University
state: Sichuan
city: Chongqing
country: China
facility: West China Hospital Of Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: The First Affiliated Hospital Of Zhejiang University
state: Zhejiang
Study officials:
affiliation: Department of Infectious Diseases,Peking University First Hospital
name: Yu Yan yan, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Huashan Hospital
name: Shi Guang feng, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Jiaotong University Affiliated Ruijin Hospital
name: Xie Qing, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: West China Hospital
name: Tang Hong, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Zhang Da zhi, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital Of The Third Mililary Medical University
name: Mao Qing, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology
name: Ning Qin, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Li Jun, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhejiang University
name: Sheng Ji fang, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Beijing You An Hospital,Capital Medical University
name: Cheng Xin fang, doctor
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.