Management and Monitoring of HBV Reactivation in Immunocompromised Patients in Turkey (REANT STUDY)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 490
- 试验地点
- 17
- 主要终点
- Monitoring of renal function in patients receiving antivirals.
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Positive for Anti-HBc IgG
- •Must be candidate for immunosuppressive therapy.
排除标准
- •Voluntary Withdrawal
- •Failure to attend follow-up visits
结局指标
主要结局
Monitoring of renal function in patients receiving antivirals.
时间窗: 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.
时间窗: 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.
时间窗: 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.
次要结局
- Evaluation of liver status in the patients receiving HBV antivirals.(Baseline to week 6, 12, 24, 48)
- Evaluation of liver damage in the patients receiving HBV antivirals.(Baseline to week 6, 12, 24, 48)
- Evaluation of liver stiffness in the immunosuppressive patients receiving HBV antivirals for reactivation prophylaxis.(Baseline to week 6, 12, 24, 48)
研究者
Yaşar Bayındır, MD
Chief Physican
Guven Health Group