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Clinical Trial Summary

The current study is a prospective, randomized, open, multi-center investigation. The aim of the study is to investigate whether the HBeAg seroconversion rate can be improved if applying combination therapy in HBeAg positive CHB patients who has achieved HBVDNA<105copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2.


Clinical Trial Description

The HBeAg positive chronic hepatitis B(CHB) subjects who has achieved HBV DNA<10*5copies/ml,HBsAg≤5000IU/ml, ALT≥ 2ULN or Liver histology G2S2 will be randomized to three groups. The subjects who go into group A will be treated by tenofovir disoproxil fumarate (TDF) for 96 weeks; The subjects who go into group B will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks; The subjects who go into group C will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03013556
Study type Interventional
Source Ruijin Hospital
Contact Xinxin Zhang
Email zhangx@shsmu.edu.cn
Status Recruiting
Phase Phase 4
Start date November 2016
Completion date December 31, 2021

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