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New study aims to predict hidden hepatitis b danger in transplant patients

NCT ID NCT07644026

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
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Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study will develop and test a prediction tool (nomogram) to estimate the risk of hepatitis B virus reactivation in patients who have had a past infection and are undergoing a stem cell transplant. Researchers will follow 300 patients for at least 36 months after transplant, collecting data on reactivation events. No new treatments are being tested; the goal is to create a better way to identify high-risk patients so doctors can monitor them more closely.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could give doctors a reliable way to predict which patients are at risk of hepatitis B reactivation after stem cell transplant, helping them take preventive steps.
What could go wrong
This is an observational study that only builds a prediction model, not a treatment. The model may not be accurate enough for all patients, and it won't directly prevent or cure the reactivation.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 300 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

he study population will include HBsAg-negative/anti-HBc-positive patients undergoing first allogeneic hematopoietic stem cell transplantation at the participating centers. Patients will be prospectively enrolled before conditioning and followed for subsequent hepatitis B virus (HBV) reactivation (defined as HBsAg reappearance and/or HBV DNA ≥10 IU/mL) and post-transplant outcomes, including hepatitis due to HBV reactivation, hepatic failure, HBV-related mortality, and HBsAg seroclearance after reactivation. Baseline recipient/donor HBV serology (anti-HBs titers, anti-HBc titers), antiviral prophylaxis practice, graft-versus-host disease, and cytomegalovirus reactivation will be collected to describe the incidence, timing, risk factors, and clinical course of HBV reactivation in this high-risk population.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients must meet all of the following criteria to be enrolled in the study: Planned allogeneic HSCT: Scheduled to undergo first allogeneic hematopoietic stem cell transplantation (allo-HSCT) for any hematologic malignancy or non-malignant hematologic disorder. Any donor type is permitted. Resolved HBV infection: Documentation of both of the following serological markers on a blood sample collected within 30 days prior to the start of conditioning: Hepatitis B surface antigen (HBsAg): negative Antibody to hepatitis B core antigen (anti-HBc): positive Note: Patients may be either positive or negative for anti-HBs at baseline. Willingness to follow protocol-defined monitoring: Patients (or legally authorized representatives) must agree to adhere to the study-specific HBV monitoring schedule as outlined in the protocol. Informed consent: Written informed consent obtained from the patient or a legally authorized representative prior to any study-related procedures. Exclusion Criteria: Patients meeting any of the following criteria will be excluded from the study: Co-infection with other hepatotropic viruses: Positive serology for hepatitis C virus (HCV) (anti-HCV antibody positive with detectable HCV RNA) Positive serology for hepatitis D virus (HDV) (anti-HDV antibody positive) Positive serology for human immunodeficiency virus (HIV) Pre-existing advanced liver disease: Clinical or histological evidence of liver cirrhosis (METAVIR stage F4, or imaging showing nodular liver surface/splenomegaly/varices) History of hepatic encephalopathy or variceal bleeding History of hepatocellular carcinoma (HCC) Prior solid organ transplantation (including kidney, liver, heart, or lung transplantation). Previous allogeneic HSCT (patients receiving a second or subsequent allo-HSCT are excluded; prior autologous HSCT is allowed). Active uncontrolled infection at the time of enrollment that, in the opinion of the treating physician, would preclude safe participation. Pregnancy or lactation at the time of enrollment. Female patients of childbearing potential must have a negative pregnancy test within 7 days before starting conditioning. Life expectancy \<6 months due to underlying disease or comorbid conditions, as judged by the treating physician. Inability to comply with follow-up due to geographic, psychiatric, or social reasons. Enrollment in another interventional trial that prohibits co-enrollment in observational studies (at the discretion of the principal investigator).

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As listed by the trial registrant

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How to take part

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