Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
Overview
- Phase
- Phase 4
- Intervention
- Entecavir maleate tablets
- Conditions
- Chronic Hepatitis B
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
- Enrollment
- 287
- Locations
- 9
- Primary Endpoint
- Compared with baseline, decline of serum HBV-DNA in the value
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of Entecavir maleate tablets in Chinese patients with hepatitis B
Investigators
Eligibility Criteria
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.
Arms & Interventions
HBeAg positive group
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 .
Intervention: Entecavir maleate tablets
HBeAg positive group
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 .
Intervention: blank Baraclude tablets
HBeAg positive group
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 .
Intervention: Blank maleate entecavir tablets
HBeAg positive group
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 .
Intervention: Baraclude tablets
HBeAg-negative group
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 .
Intervention: Entecavir maleate tablets
HBeAg-negative group
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 .
Intervention: blank Baraclude tablets
HBeAg-negative group
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 .
Intervention: Blank maleate entecavir tablets
HBeAg-negative group
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 .
Intervention: Baraclude tablets
Outcomes
Primary Outcomes
Compared with baseline, decline of serum HBV-DNA in the value
Time Frame: 5 years