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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Seoul St. Mary's Hospital
- Enrollment
- 226
- Locations
- 1
- Primary Endpoint
- Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups.
Study Overview
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.
- 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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
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.)
- •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
Arms & Interventions
Treatment group
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.
Intervention: Baracle Tab.® (Drug)
Outcomes
Primary Outcomes
Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups.
Time Frame: 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 Outcomes
- 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.)
- 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.)
- 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.)
Investigators
Dong-Gun Lee
professor
Seoul St. Mary's Hospital