HBV Reactivation in Immunocompromised Patients (REANT STUDY)

Sponsor
Yaşar Bayındır, MD
Study ID
NCT07529171
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Antiviral — DRUG
    Patients who take all antivirals recommended in the guidelines will be evaluated in the same group.

Study Details

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.

Key Dates

Start date
Mar 9, 2026
Status verified
Apr 2026
Primary completion
Jun 30, 2026
Completion
Dec 31, 2029

Study Design

Enrollment
490 participants (estimated)

Primary Outcome Measure

Monitoring of renal function in patients receiving antivirals. [ Time Frame: Baseline to week 6, 12, 24, 48 ]

Central Contacts