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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
226
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
Jeong Won Jang
Seoul, South Korea
Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups.
Comparing the rate of HBV reactivation between the treatment and delayed treatment groups during 3 years after hematopoietic stem cell transplantation \* Definition of HBV reactivation: HBsAg ≥ 1.0 S/CO or HBV DNA ≥ 10 IU/mL
Time frame: The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation
Comparison of the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups.
Comparing the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups. \* Definition of active hepatitis: ALT \>= 2 times of upper normal limit
Time frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
Comparison of the rate of hepatic failure related to HBV reactivation between the treatment and delayed treatment groups.
Comparing the rate of hepatic failure between the treatment and delayed treatment groups.
Time frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
Comparison of the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.
Comparing the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.
Time frame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
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