Maribavir for Epstein–Barr virus (EBV) infection in solid organ transplant recipients

Inclusion criteria

• {"criterion_text":"- Patients who have had EBV infection for more than 2 years of more than 5 logs\n- Subject must be able to understand and provide informed consent\n- Males and females age 18-30 years\n- solid organ transplant with a functioning graft\n- No previous PTLD\n- EBV IgG positive\n- CMV PCR negative\n- Female subjects of childbearing potential must have a negative pregnancy test upon study entry and must agree to use FDA approved methods of birth control for the duration of the study."}

Exclusion criteria

• {"criterion_text":"- Inability or unwillingness of a participant to give written informed consent or comply with study protocol\n- Pregnant or breast feeding\n- Known active current or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including HIV, hepatitis B, hepatitis C, zoster)\n- Serious uncontrolled concomitant major organ disease\n- Any infection requiring hospitalization and IV antibiotics within 4 weeks of screening or PO antibiotics within 2 weeks\n- Primary or secondary immunodeficiency\n- Malignancy within the last 5 years except treated basal and squamous cell cancer of the skin\n- Alcohol, drug or chemical abuse within 1 year\n- Difficult peripheral venous access\n- Treatment with any investigational agent within 4 weeks (or 5 half-lives of investigational drug, whichever is longer) of screening"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients achieving complete viral clearence after Maribavir therapy","definition_or_measurement_approach":"Not specified in the endpoint listing; study main objective describes evaluation of eradication or reduction of EBV replication load (references to viral load measurements and reductions in replication are made in the main objective)."}

Secondary endpoints

• {"endpoint_text":"- Proportion of patients with a complete elimination of viral replication during the first study phase\n- Proportion of patients needing a further maribavir course for a significant reduction of viral replication.\n- Rates of EBV recurrence after maribavir withdrawal\n- Impact of maribavir on the EBV-specific T and B-cell immune response after therapy\n- Impact on different B-cell subset phenotypes in peripheral blood.\n- Kinetics of viral replication over the course of the anti-viral therapy","definition_or_measurement_approach":"Not specified in the endpoint listings; endpoints refer to measures of viral replication (EBV viremia) and immunologic assays as described in the study objectives, but specific measurement methods are not detailed in the provided record."}

Spain

Earliest CTIS Part Ii Submission Date

11-02-2026

Latest Decision Or Authorization Date

13-05-2026

Processing Time Days

91

Number Of Sites

1

Number Of Participants

10

Primary sponsor

Full Name

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Organisation Type

Laboratory/Research/Testing facility

Country Of Registered Address

Spain