NCT02560649

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

A Prospective, Randomized, Multicenter, Open-label, Exploratory Study of Utilizing of "Response-Guided-Therapy (RGT)" Strategy on Optimal Nucleoside Analogue (NUC)-Experienced Patients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 324 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The current study is a prospective, randomized, open, multi-center investigation. The aim of current study is to investigate whether the HBsAg clearance rate can be improved if applying RGT strategy in HBeAg positive CHB patients treated by NUC achieved HBVDNA\<1000copies/ml，and HBsAg\<5000IU/ml; \&HBeAg\<100PEIU/ml (or470s/co), combined with PEG-IFN a-2a for 24 weeks. Then the subjects will be divided into three groups according to qHBsAg levels of week 24 (RGT). For the subjects who qHBsAg\<200IU/ml of week 24, they are defined in Group A; the subjects in Group A will continue to be treated by NUC combined with PEG-IFN a-2a 180μg for another 24 weeks(total will be 48 weeks). If the qHBsAg at week 24 did not achieve minor 200IU/ml, the subjects will be randomized to 2 groups: Group B: the subjects will continue to be treated by NUC combined with PEG-IFN a-2a 180μg for another 24 weeks (total will be 48 weeks); Group C: the subjects will be treated by NUC until 48 weeks.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2a plus Entecavir	Peginterferon alfa-2a 180μg /wk plus Entecavir 0.5mg qd for 48 weeks(Arm A and B)
DRUG	Peginterferon alfa-2a plus Lamivudine	Peginterferon alfa-2a 180μg /wk plus Lamivudine 0.1g qd for 48 weeks(Arm A and B)
DRUG	Peginterferon alfa-2a plus Adefovir	Peginterferon alfa-2a 180μg /wk plus Adefovir 10mg qd for 48 weeks(Arm A and B)
DRUG	Peginterferon alfa-2a plus Tenofovir	Peginterferon alfa-2a 180μg /wk plus Tenofovir 300mg qd for 48 weeks(Arm A and B)
DRUG	Entecavir	Entecavir 0.5mg qd for 24 weeks(Arm C)
DRUG	Lamivudine	Lamivudine 0.1g qd for 24 weeks(Arm C)
DRUG	Adefovir	Adefovir 10mg qd for 24 weeks(ArmC)
DRUG	Tenofovir disoproxil	Tenofovir 300mg qd for 24 weeks(Arm C)

Timeline

• Start date: 2015-05-01
• Primary completion: 2016-08-01
• Completion: 2017-02-01
• First posted: 2015-09-25
• Last updated: 2015-09-25