Risk of Hepatitis B Reactivation After Bone Marrow Transplantation With Prior Hepatitis B Virus (HBV) Exposure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

69 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2016-02-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether preemptive nucleoside analogue therapy or regular virologic monitoring is the preferred method in management patients with prior exposure to hepatitis B vius (HBV) and undergoing hematopoietic stem cell transplantation (HSCT).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimal Timing of Hepatitis B Vaccination After Transplants

NCT06888479

NOT_YET_RECRUITING PHASE3

Effectiveness of the Hepatitis B Vaccine Post-Hematopoietic Stem Cell Transplant

NCT03511794

Hepatitis B

COMPLETED

Kinetic Analysis of Immune Cells in Blood and Chronic Graft-Versus-Host Disease-Affected Tissues After Allogeneic Hematopoietic Cell Transplantation

NCT07235501

Graft Versus Host Disease Hematopoietic and Lymphatic System Neoplasm Malignant Solid Neoplasm

NOT_YET_RECRUITING

Role of aGVHD Biomarkers on aGVHD Risks

NCT04284904

GVHD,Acute Biomarker

UNKNOWN

Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010

NCT03111745

Viral Infections

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Occult hepatitis B virus (HBV) reactivation has been documented in bone marrow transplantation recipients who are hepatitis B surface antigen (HBsAg)-negative but with serologic evidence of prior exposure to HBV. However detailed prospective studies documenting the incidence of reactivation and the virologic and serologic kinetics of reactivation are lacking. The investigators prospective study proposes to follow-up 50 such bone marrow transplant recipients with all serologic and virologic parameters monitored every 4 weeks. Patients with detectable HBV DNA will be started on nucleoside analogue therapy. The optimal method and duration of monitoring will also be determined from our study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Exposure to Hepatitis B Virus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

HBsAg-negative, anti-HBc-positive

HBsAg-negative, anti-HBc-positive subjects undergoing hematopoietic stem cell transplantation (HSCT)

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Documented HBsAg-negative HSCT recipient with or without antibody to the hepatitis B surface antigen (anti-HBs).
* Documented anti-HBc (total)-positive.

Exclusion Criteria

* Concomitant liver diseases including chronic hepatitis C and D infection, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis and primary sclerosing cholangitis.
* Significant alcohol intake (\>30 grams per day)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No