Monitoring hepatitis B reactivation and antiviral side effects in people starting immunosuppressive treatment
Official title: Management and Monitoring of HBV Reactivation in Immunocompromised Patients in Turkey (REANT STUDY)
Run by Guven Health Group · NCT07529171 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 490 (estimated) |
| Sponsor | Guven Health Group Academic / other |
| Locations | 16 sites (Adana and 15 other locations) |
| Status | Recruiting |
| Started | March 9, 2026 |
| Main results expected | August 30, 2026 |
| Study ends | December 31, 2029 |
| Registry record updated | August 4, 2026 |
| Trial ID | NCT07529171 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Cukurova University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Adana, Turkey (Türkiye) Recruiting -
Ankara Gazi University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Ankara, Turkey (Türkiye) Recruiting -
Bilkent City Hospital Department of Infectious Diseases and Clinical Microbiology
Ankara, Turkey (Türkiye) Recruiting -
Akdeniz University, Faculty of Medicine, Department of Infectious Diseases and Clinical Mİcrobiology
Antalya, Turkey (Türkiye) Recruiting -
Dicle University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Diyarbakır, Turkey (Türkiye) Recruiting -
Diyarbakir, Memorial Hospital Department of Infectious Diseases and Clinical Microbiology
Diyarbakır, Turkey (Türkiye) Recruiting
Show 10 more locations
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Bolu Düzce University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Düzce, Turkey (Türkiye) Recruiting -
Gaziantep University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Gaziantep, Turkey (Türkiye) Recruiting -
Istanbul Haydarpaşa Numune Training and Research Hospital
Istanbul, Turkey (Türkiye) Recruiting -
Istanbul Sancaktepe Martyr Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul, Turkey (Türkiye) Recruiting -
Ege University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Izmir, Turkey (Türkiye) Recruiting -
Kocaeli University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Kocaeli, Turkey (Türkiye) Recruiting -
Rize Recep Tayyip Erdogan University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Rize, Turkey (Türkiye) Recruiting -
Samsun Ondokuz Mayıs University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Samsun, Turkey (Türkiye) Recruiting -
Şanlıurfa Harran University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Sanliurfa, Turkey (Türkiye) Recruiting -
Sivas Cumhuriyet University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Sivas, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: cigdem Mermutluoglu — Dicle University, Medical Faculty
- Study coordinator: Cigdem Mermutluoglu, MD, Assoc. Prof.
- Email: cigdemmermut@gmail.com
- Phone: +905052252700
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.