HBV Reactivation in Immunocompromised Patients (REANT STUDY)
ConditionHBV
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorYaşar Bayındır, MD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged 18 years or older
Positive for Anti-HBc IgG
Must be candidate for immunosuppressive therapy.
Disqualifiers
Voluntary Withdrawal
Failure to attend follow-up visits
Trial 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:
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Antiviral
DrugPatients who take all antivirals recommended in the guidelines will be evaluated in the same group.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline to week 6, 12, 24, 482
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.
Time frame
Baseline to week 6, 12, 24, 483
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.
Time frame
Baseline to week 6, 12, 24, 48Secondary outcomes
1
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.
Time frame
Baseline to week 6, 12, 24, 482
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.
Time frame
Baseline to week 6, 12, 24, 483
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.
Time frame
Baseline to week 6, 12, 24, 48Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Yaşar Bayındır, MD
Lead sponsor
Guven Health Group
Sponsor institution
SOUTHEAST NEUROLOGY AND INFECTIOUS DISEASES SOCIETY
Collaborator
Source ClinicalTrials.gov