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NCT Number: NCT07529171

HBV Reactivation in Immunocompromised Patients (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.

Recruiting

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Key information

Conditions

HBV

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antiviral

Drug

Patients who take all antivirals recommended in the guidelines will be evaluated in the same group.

Other names: Nucleoz(t)ide antivirals

Primary outcomes

  1. Monitoring of renal function in patients receiving antivirals.

    Time frame: Baseline to week 6, 12, 24, 48

    To assess the composite changes in renal function (GFR decline, proteinuria, etc) from baseline to month 48.

  2. Monitoring of bone health in patients receiving antivirals.

    Time frame: Baseline to week 6, 12, 24, 48

    To assess the composite changes in bone health (Reduction in T-scores via DEXA) from baseline to month 48.

  3. Monitoring of metabolic status in patients receiving antivirals.

    Time frame: Baseline to week 6, 12, 24, 48

    To assess the composite changes in metabolic status (HOMA-IR elevation, lipid profile alterations, etc) from baseline to month 48.

Secondary outcomes

  1. Evaluation of liver status in the patients receiving HBV antivirals.

    Time frame: Baseline to week 6, 12, 24, 48

    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.

  2. Evaluation of liver damage in the patients receiving HBV antivirals.

    Time frame: Baseline to week 6, 12, 24, 48

    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.

  3. Evaluation of liver stiffness in the immunosuppressive patients receiving HBV antivirals for reactivation prophylaxis.

    Time frame: Baseline to week 6, 12, 24, 48

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Cigdem Mermutluoglu

CONTACT

[email protected]

+905052252700

Mustafa Kemal Celen

CONTACT

[email protected]

+905336207022

Sponsors and collaborators

Lead sponsor

Yaşar Bayındır, MD

Other

Collaborators

  • SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2029
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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