Clinical Trial: Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

Study Status: No longer available
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Emtricitabine for Naive Child Chinese Chronic Hepatitis B Patients

Brief Summary: This study evaluates generic emtricitabine(FTC) in Chinese naive children chronic hepatitis B patients. Single group of child patients were enrolled, which include HBeAg positive and 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 in children paitients. The investigators design this trial to test the effect of FTC in Chinese children CHB which including naive HBeAg positive and Negative CHB patients.
Sponsor: Asian-Pacific Alliance of Liver Disease, Beijing

Current Primary Outcome: virological response rate [ Time Frame: week 48 ]

HBV DNA < 500 copies/ml


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

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

Dates:
Date Received: December 23, 2014
Date Started: January 2015
Date Completion: July 2016
Last Updated: December 29, 2014
Last Verified: December 2014