HBV Reactivation in Immunocompromised Patients (REANT STUDY)
Management and Monitoring of HBV Reactivation in Immunocompromised Patients in Turkey (REANT STUDY)
1 other identifier
observational
490
1 country
1
Brief Summary
Background/Objective: Comorbidities represent a critical risk factor in the prognosis of patients receiving immunosuppressive therapy. For patients with anti-HBc IgG positivity requiring Hepatitis B virus (HBV) prophylaxis, the long-term physiological impact of oral antivirals remains a concern. This study aims to prospectively monitor bone, renal, and metabolic dysfunctions associated with oral antiviral use and other systemic risk factors over a long-term period. Methods: The REANT Cohort is designed as a 4-year, multicenter prospective study. The cohort will consist of patients initiated on HBV prophylaxis due to immunosuppressive treatment. Participants will undergo regular longitudinal assessments to evaluate bone mineral density, renal filtration and tubular functions, and metabolic profiles. The interplay between antiviral therapy, baseline comorbidities, and long-term organ dysfunction will be analyzed. Conclusion: The findings from the REANT Cohort are expected to provide robust evidence regarding the safety of long-term HBV prophylaxis and assist in the development of monitoring guidelines for immunosuppressed patients with latent HBV infection.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2026
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 9, 2026
CompletedFirst Submitted
Initial submission to the registry
April 4, 2026
CompletedFirst Posted
Study publicly available on registry
April 14, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
April 14, 2026
April 1, 2026
4 months
April 4, 2026
April 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Monitoring of renal function in patients receiving antivirals.
To assess the composite changes in renal function (GFR decline, proteinuria, etc) from baseline to month 48.
Baseline to week 6, 12, 24, 48
Monitoring of bone health in patients receiving antivirals.
To assess the composite changes in bone health (Reduction in T-scores via DEXA) from baseline to month 48.
Baseline to week 6, 12, 24, 48
Monitoring of metabolic status in patients receiving antivirals.
To assess the composite changes in metabolic status (HOMA-IR elevation, lipid profile alterations, etc) from baseline to month 48.
Baseline to week 6, 12, 24, 48
Secondary Outcomes (3)
Evaluation of liver status in the patients receiving HBV antivirals.
Baseline to week 6, 12, 24, 48
Evaluation of liver damage in the patients receiving HBV antivirals.
Baseline to week 6, 12, 24, 48
Evaluation of liver stiffness in the immunosuppressive patients receiving HBV antivirals for reactivation prophylaxis.
Baseline to week 6, 12, 24, 48
Interventions
Patients who take all antivirals recommended in the guidelines will be evaluated in the same group.
Eligibility Criteria
The REANT Cohort is designed as a nationwide, multicenter study conducted across 14 specialized centers in Türkiye. These centers have been strategically selected to reflect a broad geographical and demographic diversity, ensuring a robust representation of the patient population receiving HBV prophylaxis. Participating Provinces: The study will be carried out simultaneously in the following 13 provinces (with 14 participating clinical sites): Ankara, Sivas, İstanbul, Kocaeli, İzmir, Antalya, Adana, Gaziantep, Şanlıurfa, Diyarbakır, Samsun, Rize, Düzce Sample Size Projection:
You may qualify if:
- Aged 18 years or older
- Positive for Anti-HBc IgG
- Must be candidate for immunosuppressive therapy.
You may not qualify if:
- Voluntary Withdrawal
- Failure to attend follow-up visits
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dicle University
Diyarbakır, TR-21280, Turkey (Türkiye)
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Yaşar Bayındır
Guven Hospital
- PRINCIPAL INVESTIGATOR
cigdem Mermutluoglu
Dicle University, Medical Faculty
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 48 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chief Physican
Study Record Dates
First Submitted
April 4, 2026
First Posted
April 14, 2026
Study Start
March 9, 2026
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2029
Last Updated
April 14, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- After publication and then.
- Access Criteria
- Data will be shared with qualified academic researchers who provide a methodologically sound proposal. To gain access, data requestors must sign a data use agreement (DUA) and provide proof of institutional review board (IRB) or ethics committee approval for their secondary analysis. The requested data must be used solely for the purposes of the approved research proposal.
De-identified individual participant data collected during the trial will be made available upon reasonable request to qualified researchers for academic purposes following the publication of the primary study results.