NCT04942886

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

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

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: Seoul St. Mary's Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 70 Years
• Healthy volunteers: Not accepted

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 allogeneic hematopoietic stem cell transplantation.

Detailed 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 allogeneic 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=113) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after allogeneic 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=113) 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.

Conditions

• Hepatitis B Reactivation
• Hematopoietic Stem Cell Transplantation
• Antiviral Drug
• HBV

Interventions

Type	Name	Description
DRUG	Baracle Tab.®	The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.

Timeline

• Start date: 2021-08-21
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2021-06-29
• Last updated: 2025-07-18

Locations

1 site across 1 country: South Korea