HBV Reactivation in Immunocompromised Patients (REANT STUDY)

Официальное название

Management and Monitoring of HBV Reactivation in Immunocompromised Patients in Turkey (REANT STUDY)

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Monitoring of renal function in patients receiving antivirals. [Срок оценки: Baseline to week 6, 12, 24, 48]
• Monitoring of bone health in patients receiving antivirals. [Срок оценки: Baseline to week 6, 12, 24, 48]
• Monitoring of metabolic status in patients receiving antivirals. [Срок оценки: Baseline to week 6, 12, 24, 48]

Вторичные конечные точки (3)

• Evaluation of liver status in the patients receiving HBV antivirals. [Срок оценки: Baseline to week 6, 12, 24, 48]
• Evaluation of liver damage in the patients receiving HBV antivirals. [Срок оценки: Baseline to week 6, 12, 24, 48]
• Evaluation of liver stiffness in the immunosuppressive patients receiving HBV antivirals for reactivation prophylaxis. [Срок оценки: Baseline to week 6, 12, 24, 48]

Критерии участия

Критерии включения

• Aged 18 years or older
• Positive for Anti-HBc IgG
• Must be candidate for immunosuppressive therapy.

Критерии исключения

• Voluntary Withdrawal
• Failure to attend follow-up visits

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Turkey (Türkiye) · 16 центров

• Cukurova University, Faculty of Medicine, Department of Infectious Diseases and Clinical M — Adana
• Ankara Gazi University, Faculty of Medicine, Department of Infectious Diseases and Clinica — Ankara
• Bilkent City Hospital Department of Infectious Diseases and Clinical Microbiology — Ankara
• Akdeniz University, Faculty of Medicine, Department of Infectious Diseases and Clinical Mİ — Antalya
• Dicle University, Faculty of Medicine, Department of Infectious Diseases and Clinical Micr — Diyarbakır
• Diyarbakir, Memorial Hospital Department of Infectious Diseases and Clinical Microbiology — Diyarbakır
• Bolu Düzce University, Faculty of Medicine, Department of Infectious Diseases and Clinical — Düzce
• Gaziantep University, Faculty of Medicine, Department of Infectious Diseases and Clinical — Gaziantep
• … и ещё 8 центров

Идентификаторы

NCT: NCT07529171 · REANT STUDY-GVN

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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