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

• Status: Completed
• Trial end date: 2014-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.; Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
• Treatments: Entecavir; Maleic acid

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.