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

  • 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.

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.