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HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial
Sponsor: Oriol Manuel
Summary
Cytomegalovirus (CMV) remains a significant cause of morbidity and mortality following organ transplantation. Cell-mediated immunity plays a crucial role in controlling CMV replication after transplantation. Immune monitoring involves the use of immune biomarkers to dynamically estimate the risk of CMV replication. This approach allows for the individualization of preventive and therapeutic strategies, improving patient outcomes. The HORUS-COPE trial is designed to assess the effect of immune modulation on CMV replication kinetics and to explore the performance of a selected immune signature during antiviral therapy for CMV infection to stratify patients based on their risk of not responding to immune modulation.
Official title: HORUS-Cytomegalovirus Open Proof-of-concept Exploratory Trial (HORUS-COPE): An International Proof-of-concept Clinical Trial on Modulation of Immunosuppressive Regimen in Solid-organ Transplant Recipients With Cytomegalovirus Infection.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2026-04
Completion Date
2028-03
Last Updated
2026-05-06
Healthy Volunteers
No
Conditions
Interventions
50% reduction in the dose of MPA
50% reduction in the dose of MPA with standard antiviral therapy
Switch from MPA to a mammalian target of rapamycin inhibitor (mTORi), together with an adapted dose of tacrolimus
Switch from MPA to a mammalian target of rapamycin inhibitor (mTORi), together with an adapted dose of tacrolimus, with standard antiviral therapy
standard antiviral therapy along with maintenance of their initial immunosuppressive therapy.
standard antiviral therapy along with maintenance of their initial immunosuppressive therapy (control group)
Locations (4)
Centre hospitalier universitaire Bordeaux (CHU Bordeaux)
Bourdeaux, Talence Cedex, France
Centre hospitalier universitaire Toulouse (CHU Toulouse)
Toulouse, Toulouse, France
Hospital Universitari Vall D'Hebron
Barcelona, Catalonia, Spain
Centre hospitalier universitaire vaudois (CHUV)
Lausanne, Canton of Vaud, Switzerland