Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
This trial is active, not recruiting.
|Condition||chronic hepatitis b|
|Treatments||entecavir maleate tablets, blank baraclude tablets, blank maleate entecavir tablets, baraclude tablets|
|Sponsor||Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd|
|Start date||October 2008|
|End date||March 2014|
|Trial size||287 participants|
|Trial identifier||NCT01926288, CTTQ805-4|
The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B
|United States||No locations recruiting|
|Other countries||No locations recruiting|
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|Beijing, China||Department of Infectious Diseases,Peking University First Hospital||no longer recruiting|
|Beijing, China||Beijing You An Hospital,Capital Medical University||no longer recruiting|
|Chongqing, China||The First Affiliated Hospital Of The Third Mililary Medical University||no longer recruiting|
|Wuhan, China||Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology||no longer recruiting|
|Nanjing, China||The First Affiliated Hospital Of Nanjing Medical University||no longer recruiting|
|Shanghai, China||Shanghai Jiaotong University Affiliated Ruijin Hospital||no longer recruiting|
|Chongqing, China||West China Hospital Of Sichuan University||no longer recruiting|
|Chongqing, China||The Second Affiliated Hospital Of Chongqing Medical University||no longer recruiting|
|Hangzhou, China||The First Affiliated Hospital Of Zhejiang University||no longer recruiting|
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Compared with baseline, decline of serum HBV-DNA in the value
time frame: 5 years
Male or female participants from 18 years up to 65 years old.
- 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.
- 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.
|Official title||Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B|
|Principal investigator||Yu Yan yan, doctor|
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