Clinical Trial

HBV Reactivation in Immunocompromised Patients (REANT STUDY)

Recruiting
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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.
Protocol Amendment History 2 changes
notable Trial sites expanded: 1 -> 16 locations 2026-08-05
notable Primary completion pushed: 2026-06-30 -> 2026-08-30 2026-08-05
Trial Details
NCT Number NCT07529171
Lead Sponsor Yaşar Bayındır, MD
Collaborators: SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
Conditions HBV
Enrollment 490 participants
Start Date 2026-03-09
Primary Completion 2026-08-30 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-04