Overview

This trial is active, not recruiting.

Condition chronic hepatitis b
Treatments entecavir maleate tablets, blank baraclude tablets, blank maleate entecavir tablets, baraclude tablets
Phase phase 4
Sponsor Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd
Start date October 2008
End date March 2014
Trial size 287 participants
Trial identifier NCT01926288, CTTQ805-4

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Other)
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 .
entecavir maleate tablets
blank baraclude tablets
blank maleate entecavir tablets
baraclude tablets
(Other)
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 .
entecavir maleate tablets
blank baraclude tablets
blank maleate entecavir tablets
baraclude tablets

Primary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

Official title Efficacy and Safety of Entecavir Maleate Tablets in Chinese Patients With Hepatitis B
Principal investigator Yu Yan yan, doctor
Trial information was received from ClinicalTrials.gov and was last updated in August 2013.
Information provided to ClinicalTrials.gov by Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd.