Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem… (NCT04942886) | Clinical Trial Compass
By InvitationNot Applicable
Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
South Korea226 participantsStarted 2021-08-21
Plain-language 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.
Who can participate
Age range
19 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups.
Timeframe: The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation