Clinical Trial: Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Emtricitabine for Naive Chinese Chronic Hepatitis B Patients

Brief Summary: This study evaluates generic emtricitabine(FTC) in Chinese naive chronic hepatitis B patients. Patients were divided into 2 groups: HBeAg positive Chronic hepatitis B(CHB)group and HBeAg negative Chronic hepatitis B(CHB)group.

Detailed Summary: Generic emtricitabine(FTC) has been approved for treatment of naive chronic hepatitis B(CHB) patients in China. Yet data are limited for this agent. The investigators design this trial to test the effect of FTC in Chinese CHB which including naive HBeAg positive and Negative CHB patients. Response guided therapy strategy is adopted for patients who can not achieve HBV DNA negativity at week 24 FTC treatment, which means FTC and adefovir are combined for these patients.
Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing

Current Primary Outcome: virological response rate [ Time Frame: week 96 ]

HBV DNA < 500 copies/ml


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • HBV DNA decrease level [ Time Frame: week24, 48, 72 and 96 ]
    HBV DNA decrease compared with baseline（log10 copies/ml）
  • HBV DNA negativity rate [ Time Frame: week 24, 48 and 72 ]
    HBV DNA < 500 copies/ml
  • biochemical response [ Time Frame: week 24,48,72 and 96 ]
    ALT normalization
  • HBeAg loss [ Time Frame: week 24,48,72 and 96 ]
    HBeAg loss in HBeAg positive group
  • HBeAg seroconversion [ Time Frame: week 24,48,72 and 96 ]
    HBeAg seroconversion in HBeAg positive group
  • HBeAg reversion [ Time Frame: week 24,48,72 and 96 ]
    HBeAg positive in Baseline HBeAg negativie group patients
  • HBsAg loss [ Time Frame: week 24,48,72 and 96 ]
    HBsAg loss in both group
  • HBsAg seroconversion [ Time Frame: week 24,48,72 and 96 ]
    HBsAg loss and anti-HBs positive
  • adverse event [ Time Frame: week 24,48,72 and 96 ]
    type and rate of adverse events;type and rate of severe adverse event;
  • HBV genetic resistance to emtricitabine and adefovir [ Time Frame: week 24,48,72 and 96 ]
    HBV genetic resistance to emtricitabine and adefovir


Original Secondary Outcome: Same as current

Information By: Asian-Pacific Alliance of Liver Disease, Beijing

Dates:
Date Received: December 23, 2014
Date Started: December 2014
Date Completion: December 2017
Last Updated: December 29, 2014
Last Verified: December 2014