Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B

Chronic Hepatitis B Clinical Trial

Official title:

Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01926288
• Other study ID #: CTTQ805-4
• Status: Completed
• Phase: Phase 4
• First received: August 13, 2013
• Last updated: December 27, 2017
• Start date: October 2008
• Est. completion date: March 2014

Study information

• Verified date: August 2013
• Source: Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B

Recruitment information / eligibility

• Status: Completed
• Enrollment: 287
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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, a1 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.

Related Conditions & MeSH terms

• Chronic Hepatitis B
• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic

Intervention

Drug:
• Entecavir maleate tablets

• blank Baraclude tablets

• Blank maleate entecavir tablets

• Baraclude tablets

Locations

Country	Name	City	State
China	Beijing You An Hospital,Capital Medical University	Beijing	Beijing
China	Department of Infectious Diseases,Peking University First Hospital	Beijing	Beijing
China	The First Affiliated Hospital Of The Third Mililary Medical University	Chongqing	Chongqing
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	The First Affiliated Hospital Of Nanjing Medical University	Nanjing	Jiangsu
China	Shanghai Jiaotong University Affiliated Ruijin Hospital	Shanghai	Shanghai
China	Tongji Medical College of Hust Tongji Medical College Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compared with baseline, decline of serum HBV-DNA in the value		5 years