drugset / Trial / NCT02560649

An Exploratory Study of RGT Strategy on Optimal NUC-experienced Patients

NCT02560649

Phase 4 Unknown 324 enrolled Ruijin Hospital
RandomizedOpen-labelTreatment

Summary

The aim of current study is to investigate whether the HBsAg clearance rate can be improved if applying RGT((Response-Guided Therapy) strategy in HBeAg positive CHB(chronic hepatitis B) patients treated by nucleoside analogue(NUC) achieved HBVDNA\<1000copies/ml,and HBsAg\<5000IU/ml; \&HBeAg\<100PEIU/ml (or470s/co), combined with PEG-IFN a-2a for 24 weeks.

Timeline

Start
2015-05
Primary completion
2016-08
Completion
2017-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Adefovir Unknown 10 mg
Subject Entecavir Small molecule 0.5 mg
Subject Lamivudine Other / unclassified 0.1 g
Subject Peginterferon alfa-2a Protein / enzyme biologic 180 ug
Comparator Tenofovir disoproxil fumarate Small molecule 300 mg