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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01926288

Enrollment

287

Registered

2013-08-20

Start date

2008-10-31

Completion date

2014-03-31

Last updated

2017-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B

Brief summary

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

Interventions

DRUGEntecavir maleate tablets

DRUGblank Baraclude tablets

DRUGBlank maleate entecavir tablets

DRUGBaraclude tablets

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026