Monitoring hepatitis B reactivation and antiviral side effects in people starting immunosuppressive treatment
Management and Monitoring of HBV Reactivation in Immunocompromised Patients in Turkey (REANT STUDY)
This 4-year, multicenter project will follow adults with past hepatitis B exposure (anti-HBc IgG positive) who start antiviral prophylaxis with immunosuppressive therapy to see if the antivirals cause long-term bone, kidney, or metabolic problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 490 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Guven Health Group Academic / other |
| Locations | 1 site (Diyarbakır) |
| Trial ID | NCT07529171 on ClinicalTrials.gov |
What this trial studies
The REANT Cohort is a 4-year prospective, multicenter cohort enrolling adults who are anti-HBc IgG positive and initiating HBV prophylaxis because of planned immunosuppressive therapy. Participants will undergo regular longitudinal assessments of bone mineral density, renal filtration and tubular function, and metabolic profiles, with data captured in a centralized e-CRF. The study will analyze relationships between specific antiviral agents, baseline comorbidities, and subsequent organ dysfunction over time. Each participating center aims to enroll approximately 35 patients with enrollment scheduled to finish by June 30, 2026.
Who should consider this trial
Good fit: Adults (18 years or older) who are anti-HBc IgG positive and are candidates for immunosuppressive therapy and HBV prophylaxis are the ideal participants.
Not a fit: People without prior HBV exposure (anti-HBc negative), those not receiving antiviral prophylaxis, or individuals unable to attend regular follow-up visits are unlikely to benefit from this cohort.
Why it matters
Potential benefit: If successful, the study could clarify which antiviral approaches minimize long-term bone, kidney, and metabolic harm and help clinicians choose safer prophylaxis for patients on immunosuppression.
How similar studies have performed: Prior studies show antiviral prophylaxis prevents HBV reactivation and have reported renal and bone toxicity with certain agents, but prospective multicenter long-term cohort data specifically in immunosuppressed patients are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Diyarbakır
- Dicle University — Diyarbakır, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: cigdem Mermutluoglu — Dicle University, Medical Faculty
- Study coordinator: Cigdem Mermutluoglu
- Email: cigdemmermut@gmail.com
- Phone: +905052252700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.