HBV Reactivation in Immunocompromised Patients (REANT STUDY)

Management and Monitoring of HBV Reactivation in Immunocompromised Patients in Turkey (REANT STUDY)

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.

Study Overview

• Status: Recruiting
• Conditions: HBV
• Intervention / Treatment: Drug: Antiviral

Detailed Description

Patient Recruitment and Enrollment:

The patient enrollment phase for the study is scheduled to conclude on June 30, 2026. Each participating center is projected to enroll 35 patients, ensuring a balanced distribution of data across the multicenter framework. The study will be initiated simultaneously across all participating sites to maintain temporal consistency in data collection.

Electronic Case Report Form (e-CRF) and Coding:

Data will be managed through a centralized e-CRF system. To ensure systematic tracking and data integrity, the system will assign a unique center code to each participating institution.

Patient Identification and Confidentiality:

For each participant, a specific patient code will be automatically generated by the system. Following the standardized protocol of the study, the patient's Full Name must be entered into the system, formatted specifically with a hyphen between the first and last name (e.g., John-Doe). This structured nomenclature will ensure uniformity in the electronic database.

• Study Type: Observational
• Enrollment (Estimated): 490

Contacts and Locations

• Study Contact: Name: Cigdem Mermutluoglu; Phone Number: +905052252700; Email: cigdemmermut@gmail.com
• Study Contact Backup: Name: Mustafa Kemal Celen; Phone Number: +905336207022; Email: mkcelen@hotmail.com

Study Locations

• Turkey (Türkiye)
  • Diyarbakır, Turkey (Türkiye), TR-21280
    • Recruiting
    • Dicle University
    • Contact: Cigdem Mermutluoglu; Phone Number: +905052252700; Email: cigdemmermut@gmail.com
    • Contact: Mustafa Kemal Celen; Phone Number: +905336207022; Email: mkcelen@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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:

Description

Inclusion Criteria:

• Aged 18 years or older
• Positive for Anti-HBc IgG
• Must be candidate for immunosuppressive therapy.

Exclusion Criteria:

• Voluntary Withdrawal
• Failure to attend follow-up visits

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of liver status in the patients receiving HBV antivirals.	To evaluate changes in liver status by FIB-4 over 48 months. FIB-4 Index (Fibrosis-4 Index) is a formula that combines four different parameters to estimate the degree of liver damage. These parameters are: Age, AST (Aspartate Aminotransferase) level, ALT (Alanine Aminotransferase) level, and platelet count.	Baseline to week 6, 12, 24, 48
Evaluation of liver damage in the patients receiving HBV antivirals.	To evaluate changes in liver status by APRI over 48 months. APRI (AST to Platelet Ratio Index) is a simpler calculation focusing on the relationship between liver enzyme elevation and the decrease in platelets often seen as liver disease progresses. Parameters Used: AST level, AST Upper Limit of Normal (ULN), Platelet Count.	Baseline to week 6, 12, 24, 48
Evaluation of liver stiffness in the immunosuppressive patients receiving HBV antivirals for reactivation prophylaxis.	To evaluate changes in liver status by Fibroscan (if available in the center) over 48 months. FibroScan (also known as Transient Elastography) is a non-invasive medical imaging technique used to measure the stiffness of the liver.	Baseline to week 6, 12, 24, 48

Collaborators and Investigators

• Sponsor: Yaşar Bayındır, MD
• Collaborators: SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
• Investigators: Study Director: Yaşar Bayındır, Güven Hospital; Principal Investigator: cigdem Mermutluoglu, Dicle University, Medical Faculty

Study record dates

Study Major Dates

• Study Start (Actual): March 9, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: April 4, 2026
• First Submitted That Met QC Criteria: April 9, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Immunosuppressive therapy; HBV reactivation
• Additional Relevant MeSH Terms: Anti-Infective Agents; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses; Antiviral Agents
• Other Study ID Numbers: REANT STUDY-GVN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After publication and then.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No