2025-524845-28-00招募中4 期
HORUS-Cytomegalovirus Open Proof-of-concept Exploratory trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Change in CMV Viral Load (log10 IU/mL) from Baseline to Week 3.
研究概览
简要总结
To evaluate whether an immune modulation strategy (50% reduction in MPA dosing or a switch to everolimus) leads to a significant reduction in CMV viral load in each intervention arm, relative to maintaining the standard immunosuppressive regimen in patients with CMV infection receiving antiviral therapy.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Clinically stable adult patients (aged 18 years or older) who have received a solid organ transplant (e.g., kidney, liver, heart, lung, pancreas) and developed clinically significant CMV infection as determined by positive CMV PCR.
- •On maintenance therapy of tacrolimus, MPA, +/- steroids.
- •Informed consent signed.
排除标准
- •Active acute graft rejection or significant graft dysfunction requiring modification of the current immunosuppressive regimen, in the opinion of the investigator.
- •Receipt of more than 72 hours of antiviral therapy for CMV infection prior to enrolment, before randomization, including valganciclovir and/or IV ganciclovir therapy.
- •Known intolerance or hypersensitivity to mTOR inhibitors or to any component of the everolimus formulation.
- •Any medical condition that constitutes a contraindication to everolimus use, as judged by the investigator.
- •Additional exclusion criteria for French sites: Patient not affiliated to the French social security system OR Patient under legal protection (guardianship, curatorship).
研究组 & 干预措施
EVEROLIMUS
Test
干预措施: EVEROLIMUS (Drug)
MYCOPHENOLIC ACID
Test
干预措施: MYCOPHENOLIC ACID (Drug)
结局指标
主要结局
Change in CMV Viral Load (log10 IU/mL) from Baseline to Week 3.
Change in CMV Viral Load (log10 IU/mL) from Baseline to Week 3.
次要结局
- Change in the CMV-specific Immune Signature.
- Ability of baseline immune signature to stratify patients.
研究者
Prof. Oriol Manuel
Scientific
Centre Hospitalier Universitaire Vaudois
研究点 (3)
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