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

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

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

Conditions
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Chronic Hepatitis B

Intervention / Treatment
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* Drug: Entecavir maleate tablets
* Drug: blank Baraclude tablets
* Drug: Blank maleate entecavir tablets
* Drug: Baraclude tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: HBeAg positive group<br>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 . | Drug: Entecavir maleate tablets<br> <br> Drug: blank Baraclude tablets<br> <br> Drug: Blank maleate entecavir tablets<br> <br> Drug: Baraclude tablets<br> <br> |
| Other: HBeAg-negative group<br>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 . | Drug: Entecavir maleate tablets<br> <br> Drug: blank Baraclude tablets<br> <br> Drug: Blank maleate entecavir tablets<br> <br> Drug: Baraclude tablets<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared with baseline, decline of serum HBV-DNA in the value |  | 5 years |