HBVNCT07529171
HBV Reactivation in Immunocompromised Patients (REANT STUDY)
An observational study of HBV, run by Yaşar Bayındır, MD at 16 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- HBV
- What is being tested?
- Antiviral
- How many people
- 490 participants
- Where
- 16 sitesTurkey (Türkiye)
- Study dates
- 9 Mar 2026to 31 Dec 2029
- How long will I take part?
- 48 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The REANT Cohort is designed as a nationwide, multicenter study conducted across 14 specialized centers in Türkiye. These centers have been strategically selected to reflect a broad geographical and demographic diversity, ensuring a robust representation of the patient population receiving HBV prophylaxis. Participating Provinces: The study will be carried out simultaneously in the following 13 provinces (with 14 participating clinical sites): Ankara, Sivas, İstanbul, Kocaeli, İzmir, Antalya, Adana, Gaziantep, Şanlıurfa, Diyarbakır, Samsun, Rize, Düzce Sample Size Projection:
Who may be able to join
- Aged 18 years or older
- Positive for Anti-HBc IgG
- Must be candidate for immunosuppressive therapy.
Who cannot join
- Voluntary Withdrawal
- Failure to attend follow-up visits
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
Turkey (Türkiye)16 sites, 16 recruiting
- Recruiting
Cukurova University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Adana
Yesim Tasova, MD, Prof., +905353088511, ytasova@gmail.com
Yesim Tasova, MD, Prof.
- Recruiting
Ankara Gazi University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Ankara
Yesim Yildiz, MD, Assoc. Prof., +905556109871, ysmyldz6@gmail.com
Yesim Yildiz, MD, Assoc. Prof.
- Recruiting
Bilkent City Hospital Department of Infectious Diseases and Clinical Microbiology
Ankara
Aliye Bastug, MD, Prof., +905333814223, dr.aliye@yahoo.com
Aliye Bastug, MD, Prof.
- Recruiting
Akdeniz University, Faculty of Medicine, Department of Infectious Diseases and Clinical Mİcrobiology
Antalya
Dilara Inan, MD, Prof., +905323706725, dilarainan2004@yahoo.com
Dılara Inan, MD, Prof.
- Recruiting
Dicle University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Diyarbakır
Cigdem Mermutluoglu, MD, Assoc. Prof., +905052252700, cigdemmermut@gmail.com
Mustafa Kemal Celen, MD, Prof., +905336207022, mkcelen@hotmail.com
- Recruiting
Diyarbakir, Memorial Hospital Department of Infectious Diseases and Clinical Microbiology
Diyarbakır
Yakup Demir, MD, +905446540047, yakupdemir36@gmail.com
Yakup Demir, MD
- Recruiting
Bolu Düzce University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Düzce
Nevin Ince, MD, Assoc. Prof., +905053505839, drnevince@gmail.com
Nevin Ince, MD, Assoc. Prof.
- Recruiting
Gaziantep University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Gaziantep
Ayse Ozlem Mete, MD, Assoc. Prof., +905064883309, ayseozlem_ornek@hotmail.com
Ayse Ozlem Mete, MD, Assoc. Prof.
- Recruiting
Istanbul Haydarpaşa Numune Training and Research Hospital
Istanbul
Seniha Senbayrak, MD, Prof., +905055618792, senihasen@gmail.com
Seniha Senbayrak, MD, Prof.
- Recruiting
Istanbul Sancaktepe Martyr Prof. Dr. İlhan Varank Training and Research Hospital
Istanbul
Eyup Arslan, MD, +905324972976, dreyuparslan@hotmail.com
Eyup Arslan, MD
- Recruiting
Ege University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Izmir
Husnu Pullukcu, MD, Prof., +905334231918, husnup@yahoo.com
Husnu Pullukcu, MD, Prof.
- Recruiting
Kocaeli University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Kocaeli
Sıla Akhan, MD, Prof., +905322666535, silaakhan@gmail.com
Muge Toygar Deniz, MD, Assoc. Prof.
- Recruiting
Rize Recep Tayyip Erdogan University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Rize
Ilknur Esen Yildiz, MD, Assoc. Prof., +905057954452, iesenyildiz61@gmail.com
Ilknur Esen Yildiz, MD, Assoc. Prof.
- Recruiting
Samsun Ondokuz Mayıs University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Samsun
Ozgur Gunal, MD, Prof., +905052543167, ozgurgop@yahoo.com
Ozgur Gunal, MD, Prof.
- Recruiting
Şanlıurfa Harran University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Sanliurfa
Tuba Damar Cakirca, MD, Prof., +905444495379, dr.tubadamar@gmail.com
Tuba Damar Cakirca, MD, Prof.
- Recruiting
Sivas Cumhuriyet University, Faculty of Medicine, Department of Infectious Diseases and Clinical Microbiology
Sivas
Seyit Ali Buyuktuna, MD, Prof., +905053869882, alibuyuktuna@gmail.com
Seyit Ali Buyuktuna, MD, Prof.
About this study
Official title: Management and Monitoring of HBV Reactivation in Immunocompromised Patients in Turkey (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.
Read the detailed description
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.
- Conditions
- HBV
- Being tested
- Antiviral
- Keywords
- HBV reactivation, Immunosuppressive therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntiviralDrug
Also called Nucleoz(t)ide antivirals
Patients who take all antivirals recommended in the guidelines will be evaluated in the same group.
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitoring of renal function in patients receiving antivirals.
To assess the composite changes in renal function (GFR decline, proteinuria, etc) from baseline to month 48.
Measured: Baseline to week 6, 12, 24, 48
Monitoring of bone health in patients receiving antivirals.
To assess the composite changes in bone health (Reduction in T-scores via DEXA) from baseline to month 48.
Measured: Baseline to week 6, 12, 24, 48
Monitoring of metabolic status in patients receiving antivirals.
To assess the composite changes in metabolic status (HOMA-IR elevation, lipid profile alterations, etc) from baseline to month 48.
Measured: Baseline to week 6, 12, 24, 48
Secondary outcomes (3)
Evaluation of liver status in the patients receiving HBV antivirals.
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.
Measured: Baseline to week 6, 12, 24, 48
Evaluation of liver damage in the patients receiving HBV antivirals.
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.
Measured: Baseline to week 6, 12, 24, 48
Evaluation of liver stiffness in the immunosuppressive patients receiving HBV antivirals for reactivation prophylaxis.
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.
Measured: Baseline to week 6, 12, 24, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start9 Mar 2026
- Primary completion30 Aug 2026 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 490 participants (estimated)
- Target duration
- 48 Months
Sponsor and investigators
- Lead sponsor
- Yaşar Bayındır, MD
- Sponsor type
- University, hospital or other
- Collaborators
- SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
- Responsible party
- Sponsor-investigator, Yaşar Bayındır, MD, Guven Health Group
- Investigators
- Yasar Bayındır, MD, Prof., Study director, Guven Hospitalcigdem Mermutluoglu, Principal investigator, Dicle University, Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07529171
- Sponsor's protocol ID
- REANT STUDY-GVN
- Status last verified
- Aug 2026
- First submitted
- 4 Apr 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data collected during the trial will be made available upon reasonable request to qualified researchers for academic purposes following the publication of the primary study results.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Monitoring of HBV Reactivation in Immunocompromised Patients in Turkey (REANT STUDY)
- ClinicalTrials.gov ID
- NCT07529171
- Acronym / sponsor ID
- REANT STUDY-GVN
- Conditions
- HBV
- Keywords
- HBV reactivation, Immunosuppressive therapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Yaşar Bayındır, MDUniversity, hospital or other
- Collaborators
- SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 48 Months
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The REANT Cohort is designed as a nationwide, multicenter study conducted across 14 specialized centers in Türkiye. These centers have been strategically selected to reflect a broad geographical and demographic diversity, ensuring a robust representation of the patient population receiving HBV prophylaxis. Participating Provinces: The study will be carried out simultaneously in the following 13 provinces (with 14 participating clinical sites): Ankara, Sivas, İstanbul, Kocaeli, İzmir, Antalya, Adana, Gaziantep, Şanlıurfa, Diyarbakır, Samsun, Rize, Düzce Sample Size Projection:
Key inclusion criteria (3 listed)
- Aged 18 years or older
- Positive for Anti-HBc IgG
- Must be candidate for immunosuppressive therapy.
Key exclusion criteria (2 listed)
- Voluntary Withdrawal
- Failure to attend follow-up visits
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntiviralAlso: Nucleoz(t)ide antiviralsPatients who take all antivirals recommended in the guidelines will be evaluated in the same group. | Drug | – |
Primary outcome
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.
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.
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.
3 secondary outcomes
Evaluation of liver status in the patients receiving HBV antivirals.
Time frame: Baseline to week 6, 12, 24, 48
Evaluation of liver damage in the patients receiving HBV antivirals.
Time frame: Baseline to week 6, 12, 24, 48
Evaluation of liver stiffness in the immunosuppressive patients receiving HBV antivirals for reactivation prophylaxis.
Time frame: Baseline to week 6, 12, 24, 48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data collected during the trial will be made available upon reasonable request to qualified researchers for academic purposes following the publication of the primary study results.
Related trials for HBV
Active, not recruitingPhase 1/2
A Clinical Study of HT-101 and/or HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
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A Clinical Study of HT-101 and HT-102 in Patients With Chronic Hepatitis B Virus Infection
Chronic Hepatitis B
Not yet recruitingPhase 1
Phase Ia/Ib Trial of SCTA02A Injection in Healthy Adults and Patients With Chronic Hepatitis B
Hepatitis B
Recruiting
HIV/HBV/HCV Triple Screening in Primary Care
HIV, HBV (Hepatitis B Virus)
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yasar Bayındır, MD, Prof. study director
Guven Hospital
cigdem Mermutluoglu principal investigator
Dicle University, Medical Faculty
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HBV, run by Yaşar Bayındır, MD at 16 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cigdem Mermutluoglu, MD, Assoc. Prof. (+905052252700, cigdemmermut@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitoring of renal function in patients receiving antivirals. (time frame: Baseline to week 6, 12, 24, 48). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2026.