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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 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. |
|
| delayed treatment group | No Intervention | The delayed treatment group (control group) visit clinic every month and examined liver function test, HBsAg/Ab for 3 years after allogeneic hematopoietic stem cell transplantation. HBV DNA level is examined at every 3 months for 3 years after allogenic hematopoietic stem cell transplantation. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baracle Tab.® | Drug | The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeong Won Jang, Professor | Seoul St. Mary's Hospital, the catholic university of Korea | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeong Won Jang | Seoul | 06599 | South Korea |
According to the guideline of our institutional review board, the patient data could not be opened to other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 12, 2025 |
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|
| 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. | 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. | The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation. |
| Jul 15, 2025 |
| Prot_SAP_001.pdf |