drugset / Trial / NCT03332329

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

NCT03332329

Phase 4 Unknown 15 enrolled Qin Ning
NaSingle-groupOpen-labelTreatment

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).

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject Engerix-B Vaccine 60 ug
Subject Entecavir Small molecule
Subject Peginterferon alfa-2b Protein / enzyme biologic 180 ug Subcutaneous
Subject sargramostim Protein / enzyme biologic 75 ug Subcutaneous