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Sequential/Combination Therapy in Nucleoside or Nucleotide Analogue (NA)-Suppressed Chronic Hepatitis B Patients

NCT03332329 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2017-11-06

No results posted yet for this study

Summary

The aim of the prospective study is to determine whether combination/ sequential therapy with Entecavir, Peginterferon alfa-2b and immunomodulators Granulocyte Macrophage Colony Stimulating Factor (GMCSF)+vaccine could induce HBsAg loss in chronic hepatitis B patients with maintained Hepatitis B Virus (HBV) DNA suppression on long-term nucleoside or nucleotide analogue (NA).

Conditions

Interventions

DRUG

Entecavir

Entecavir is used for 96 weeks

DRUG

Granulocyte Macrophage Colony Stimulating Factor

Granulocyte-macrophage colony stimulating factor is used intermittently from baseline to week 16 and from 60 to week 84

DRUG

Y peginterferon alfa-2b

Y peginterferon alfa-2b is used for 96 weeks

DRUG

HBV vaccine

60ug HBV vaccine is used every four week for 24 weeks

Sponsors & Collaborators

  • Qin Ning

    lead OTHER

Principal Investigators

  • Qin Ning · Tongji Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-12-01
Primary Completion
2018-12-31
Completion
2019-12-31

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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 NCT03332329 on ClinicalTrials.gov