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

Phase 4

Completed

• Conditions: Chronic Hepatitis B
• Interventions: Drug: Entecavir maleate tablets; Drug: blank Baraclude tablets; Drug: Blank maleate entecavir tablets; Drug: Baraclude tablets

• Registration Number: NCT01926288
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Status Verified: 2013-08
• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-19
• Study First Posted: 2013-08-20
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Last Update Submitted: 2017-12-27
• Last Update Posted: 2017-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBeAg positive group	Baraclude tablets	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 .
HBeAg positive group	Entecavir maleate tablets	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 .
HBeAg positive group	blank Baraclude tablets	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 .
HBeAg positive group	Blank maleate entecavir tablets	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 .
HBeAg-negative group	Entecavir maleate tablets	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 .
HBeAg-negative group	blank Baraclude tablets	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 .
HBeAg-negative group	Blank maleate entecavir tablets	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 .
HBeAg-negative group	Baraclude tablets	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 .

Primary Outcome Measures

Name	Time	Method
Compared with baseline, decline of serum HBV-DNA in the value	5 years

Trial Locations

Locations (9)

Beijing You An Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, 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, China

The First Affiliated Hospital Of Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, 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