Back to resultsProphylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
Primary Purpose
Hepatitis B Reactivation, Hematopoietic Stem Cell Transplantation, Antiviral Drug
Status
Enrolling by invitation
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Entecavir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B Reactivation focused on measuring Hepatitis B Reactivation, hematopoietic stem cell transplantation, Prophylatic antiviral agents, Past HBV infection
Eligibility Criteria
Inclusion Criteria:
- Age: 19 - 70
- patients receiving hematopoietic stem cell transplantation
- HBV serologic test: HBsAg (-), anti-HBc IgG (+)
- 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.)
- 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
Sites / Locations
- Jeong Won Jang
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment group
delayed treatment group
Arm Description
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after 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.
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04942886
Brief Title
Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 21, 2021 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dong-Gun Lee
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 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 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=82) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after 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=82) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Reactivation, Hematopoietic Stem Cell Transplantation, Antiviral Drug, HBV
Keywords
Hepatitis B Reactivation, hematopoietic stem cell transplantation, Prophylatic antiviral agents, Past HBV infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after 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.
Arm Title
delayed treatment group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Entecavir
Other Intervention Name(s)
Prophylactic treatment group
Intervention Description
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
Primary Outcome Measure Information:
Title
Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups.
Description
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
Secondary Outcome Measure Information:
Title
Comparison of the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups.
Description
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.
Title
Comparison of the rate of hepatic failure related to HBV reactivation between the treatment and delayed treatment groups.
Description
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.
Title
Comparison of the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age: 19 - 70
patients receiving hematopoietic stem cell transplantation
HBV serologic test: HBsAg (-), anti-HBc IgG (+)
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.)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeong Won Jang, Professor
Organizational Affiliation
Seoul St. Mary's Hospital, the catholic university of Korea
Official's Role
Study Chair
Facility Information:
Facility Name
Jeong Won Jang
City
Seoul
ZIP/Postal Code
06599
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
According to the guideline of our institutional review board, the patient data could not be opened to other researchers.
Learn more about this trial
Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
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