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

NCT02560649 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2015-09-25

No results posted yet for this study

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.

Conditions

Interventions

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)

Sponsors & Collaborators

  • Ruijin Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-05-31
Primary Completion
2016-08-31
Completion
2017-02-28

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02560649 on ClinicalTrials.gov