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Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation

Hematopoietic Stem Cell Transplantation Clinical Trial

Official title:
A Randomized, Prospective, Comparative Study of the Effectiveness of Prophylactic Entecavir Treatment for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation

Clinical Trial Summary

This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with hematopoietic stem cell transplantation.

Clinical Trial Description

This study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with hematopoietic stem cell transplantation. In this study, patients are randomized into treatment group or delayed treatment group. * Stratified randomization (Block randomization within strata) according to the presence of HBsAb at baseline was used in this study. 1. Experimental: Treatment group (n=82) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months. * oral administration of entecavir is planned to start within 7 days after hematopoietic stem cell transplantation. 2. No Intervention: delayed treatment group (n=82) The delayed treatment group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04942886
Study type Interventional
Source Seoul St. Mary's Hospital
Contact
Status Enrolling by invitation
Phase N/A
Start date August 21, 2021
Completion date December 31, 2025
View Details
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