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

CTTQ

Status and phase: Completed; Phase 4

Conditions: Chronic Hepatitis B

Treatments: Drug: Blank maleate entecavir tablets; Drug: Baraclude tablets; Drug: blank Baraclude tablets; Drug: Entecavir maleate tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT01926288

CTTQ805-4

Details and patient eligibility

About

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

Enrollment: 287 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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287 participants in 2 patient groups

HBeAg positive group

Other group

Description:

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 .

Treatment:

Drug: blank Baraclude tablets

Drug: Blank maleate entecavir tablets

Drug: Entecavir maleate tablets

Drug: Baraclude tablets

HBeAg-negative group

Other group

Description:

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 .

Treatment:

Drug: blank Baraclude tablets

Drug: Blank maleate entecavir tablets

Drug: Entecavir maleate tablets

Drug: Baraclude tablets