Antiviral Drug, HBV, Hematopoietic Stem Cell Transplantation, Hepatitis B Reactivation
Conditions
Keywords
Hepatitis B Reactivation, hematopoietic stem cell transplantation, Prophylatic antiviral agents, Past HBV infection
Brief 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.
Interventions
DRUGBaracle Tab.®
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
Sponsors
Seoul St. Mary's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Inclusion Criteria: * Age: 19 - 70 * Patients receiving allogeneic hematopoietic stem cell transplantation * HBV serologic test: HBsAg (-), anti-HBc IgG (+) before receiving allogeneic hematopoietic stem cell transplantation * ECOG performence: 0-2 * patients with informed consent 2.
Exclusion criteria
* HBV DNA (+, ≥10 IU/mL) at the time of screening * Receiving hematopoietic stem cell transplantation from donor with HBsAg+ * Combined other chronic liver disease (severe alcoholics, autoimmune hepatitis, chronic hepatitis C etc.) * HIV (+) * Previous antiviral therapy history for chronic hepatitis B * Other concomitant malignancy * Combined autoimmune disease (rheumatic arthritis, SLE etc) * CTP class B, C * Decompensated complications (ascites, hepatic encephalopathy etc.) * Active tuberculosis * Patients with lymphoma * Patients receiving autologous hematopoietic stem cell transplantation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups. | The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups. | The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation. | 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 |
| Comparison of the rate of hepatic failure related to HBV reactivation between the treatment and delayed treatment groups. | The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation. | Comparing the rate of hepatic failure between the treatment and delayed treatment groups. |
| Comparison of 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. | Comparing the rate of survival related to HBV reactivation between the treatment and delayed treatment groups. |
Countries
South Korea
Outcome results
None listed