Hepatitis B ReactivationNCT04942886
Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
A study testing Baracle Tab.® in people with Hepatitis B Reactivation and Hematopoietic Stem Cell Transplantation, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 70 years
- Conditions the study is for
- Hepatitis B Reactivation, Hematopoietic Stem Cell Transplantation, Antiviral Drug
- What is being tested?
- Baracle Tab.®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Aug 2021to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- 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.)
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the 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.
- 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.
- Being tested
- Baracle Tab.®
- Keywords
- Hepatitis B Reactivation, hematopoietic stem cell transplantation, Prophylatic antiviral agents, Past HBV infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baracle Tab.®Drug
Also called Prophylactic treatment group
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Baracle Tab.® |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation
Secondary outcomes (3)
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
Measured: 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.
Measured: 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.
Measured: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start21 Aug 2021
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis B ReactivationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 226 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Gun Lee, Seoul St. Mary's Hospital
- Investigators
- Jeong Won Jang, Professor, Study chair, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04942886
- Sponsor's protocol ID
- KC20MISI0622
- Status last verified
- Jul 2025
- First submitted
- 15 Jun 2021
- Last updated
- 18 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: According to the guideline of our institutional review board, the patient data could not be opened to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04942886
- Acronym / sponsor ID
- KC20MISI0622
- Keywords
- Hepatitis B Reactivation, hematopoietic stem cell transplantation, Prophylatic antiviral agents, Past HBV infection
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 226 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: Baracle Tab.®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. |
Who may qualify
- Ages
- 19 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baracle Tab.®Also: Prophylactic treatment groupThe intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation. | Drug | Treatment group |
Primary outcome
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
3 secondary outcomes
Comparison of the rate of active hepatitis with HBV reactivation 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 hepatic failure 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.
Comparison of 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No. According to the guideline of our institutional review board, the patient data could not be opened to other researchers.
Related trials for Hepatitis B Reactivation
Not yet recruitingObservational study
HBV Reactivation Prediction Model in Allo-HSCT
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Entecavir Prophylaxis for Hepatitis B Reactivation for CD20 Positive B-cell Lymphoma Patients With Resolved Hepatitis B (Negative Hepatitis B Surface Antigen, Positive Hepatitis B Core Antibody)
Resolved Hepatitis B, CD20 Positive B-cell Lymphoma
Active, not recruitingPhase 4
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
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Active, not recruitingObservational study
Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy.
Occult Hepatitis B Infection in Cancer Patients
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Occult Hepatitis B Virus Infection and HBV Reactivation After Switching to Long Acting Therapy in Patients With HIV-1
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jeong Won Jang, Professor study chair
Seoul St. Mary's Hospital, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baracle Tab.® in people with Hepatitis B Reactivation and Hematopoietic Stem Cell Transplantation, run by Seoul St. Mary's Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.