Phase IV study to evaluate the safety and efficacy of maribavir in reducing Epstein–Barr virus in young adult kidney transplant recipients.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Virus Diseases [C02], Phenomena and Processes [G] - Immune system processes [G12]

Decision date (initial)

2026-05-13

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety

This is a proof-of-concept, 2-step, phase IV pilot study in which 10 young-adult SOT recipients
with persistently high EBV replication load (>2 years with >5Log EBV viremia) despite the use
of current standard-of-care therapeutic strategies (conversion to mTor-inhibitors), that will
evaluate the safety and efficacy of an initial 6-month course of maribavir at 400mg bid, to eradicate
or reduce >50% high replication load of EBV. Since the gene transcription inhibition of multiple
viral proteins is required for inhibiting viral replication, we hypothesize that a longer course of
therapy may be required in some patients thus, those patients having achieved between 25%- 50%
reduction on their viral replication during the firsts phase of the study will continue with 3
additional months of maribavir therapy to ensure a more pronounced reduction of viremia with this
therapy.

Secondary objectives 6

1. e the proportion of patients with a complete elimination of viral replication during the first study phase and the proportion of patients needing a further maribavir course for a significant reduction of viral replication.
2. To study the rates of EBV recurrence after maribavir withdrawal
3. To assess the impact of maribavir on the EBV-specific T and B-cell immune response after therapy as well as in different B-cell subset phenotypes in peripheral blood.
4. To evaluate the kinetics of viral replication over the course of the anti-viral therapy er the treatment course
5. To assess the changes on immunosuppressive therapies during the course of the treatment
6. To collect and quantify all adverse events potentially related to the anti-viral therapy.

Conditions and MedDRA coding

Transplant patients with high recurrent Epstein-Barr infection

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Patients who have had EBV infection for more than 2 years of more than 5 logs
2. Subject must be able to understand and provide informed consent
3. Males and females age 18-30 years
4. solid organ transplant with a functioning graft
5. No previous PTLD
6. EBV IgG positive
7. CMV PCR negative
8. 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 10

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

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Proportion of patients achieving complete viral clearence after Maribavir therapy

Secondary endpoints 6

1. Proportion of patients with a complete elimination of viral replication during the first study phase
2. Proportion of patients needing a further maribavir course for a significant reduction of viral replication.
3. Rates of EBV recurrence after maribavir withdrawal
4. Impact of maribavir on the EBV-specific T and B-cell immune response after therapy
5. Impact on different B-cell subset phenotypes in peripheral blood.
6. Kinetics of viral replication over the course of the anti-viral therapy

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Sponsor organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Address

Passeig De La Vall D'Hebron 119-129

City

Barcelona

Postcode

08035

Country

Spain

Scientific contact point

Organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Contact name

Oriol Bestard

Public contact point

Organisation

Fundacio Hospital Universitari Vall D’Hebron Institut De Recerca

Contact name

Oriol Bestard

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 10 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications