MARIBAVIR for Cytomegalovirus infection | Allogeneic hematopoietic stem cell transplant

Inclusion criteria

• {"criterion_text":"- Allogeneic hematopoietic stem cell transplant performed within previous twelve months."}
• {"criterion_text":"- Absence of diarrhea or other intestinal symptoms or active intestinal pathology."}
• {"criterion_text":"- Life expectancy not severely limited by concomitant illness."}
• {"criterion_text":"- Women of childbearing potential must use highly effective contraception for at least 1 month after the last dose of maribavir"}
• {"criterion_text":"- Willing and able to comply with all of the requirements and visits in the protocol."}
• {"criterion_text":"- ten and signed informed consent."}
• {"criterion_text":"- Diagnosis of CMV infection."}
• {"criterion_text":"- Patients with a medical condition that contraindicate the administration of ganciclovir, valganciclovir of foscarnet (patients with kidney failure, kidney disease, kidney dysfunction; patients with delayed state or degree of bone marrow engraftment; patients with previous CMV infections who have experienced SoC toxicity), or patients who discontinued first line antiviral therapy with ganciclovir, valganciclovir or foscarnet due to toxicity or intolerance."}
• {"criterion_text":"- Age > 18 years."}
• {"criterion_text":"- Weigh ≥40 kg."}
• {"criterion_text":"- Able to swallow tablets."}
• {"criterion_text":"- Performance status: ECOG <3."}
• {"criterion_text":"- Adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL)."}
• {"criterion_text":"- Adequate renal function (creatinine clearance ≥50 ml/min)."}

Exclusion criteria

• {"criterion_text":"- Severe vomiting, diarrhea, or other severe gastrointestinal illness within 24 hours prior to the first dose of study drug that would preclude administration of oral/enteral medication."}
• {"criterion_text":"- Any active, uncontrolled infection."}
• {"criterion_text":"- End-organ CMV disease."}
• {"criterion_text":"- Patients with other life-threatening concurrent disease."}
• {"criterion_text":"- Subjects with known hypersensitivity to any of the component medication."}
• {"criterion_text":"- Non-cooperative behaviour or non-compliance."}
• {"criterion_text":"- Participation in another clinical trial within 1 month before the start of this trial."}

Primary endpoints

• {"endpoint_text":"- The primary efficacy end point is the percentage of patients with a response to treatment, defined as plasma CMV DNA level below the lower limit of quantification (confirmed at least in two consecutive tests), at 8 weeks after the start of treatment.","definition_or_measurement_approach":"Response defined as plasma CMV DNA level below the lower limit of quantification, confirmed in at least two consecutive tests, assessed at 8 weeks after treatment start."}
• {"endpoint_text":"- The primary safety end point is the incidence of side effects that occurred or worsened during the treatment period and required maribavir therapy discontinuation.","definition_or_measurement_approach":"Incidence of adverse events that occurred or worsened during treatment and led to discontinuation of maribavir during the treatment period."}

Secondary endpoints

• {"endpoint_text":"- The secondary efficacy endpoint is to describe the incidence and frequency of CMV DNAemia detection occurring when patients are on treatment and off treatment up to 8 weeks from the discontinuation of maribavir therapy. The efficacy will be evaluated also according to the CMV infection risk.","definition_or_measurement_approach":"Incidence and frequency of CMV DNAemia detection during treatment and up to 8 weeks after discontinuation; analyses stratified by CMV infection risk."}
• {"endpoint_text":"- The secondary endpoint of late response is the proportion of patients with a partial response at 8 weeks of treatment who continued on therapy per investigator’s judgment, with a subsequent response within 12 weeks, defined as CMV DNAaemia below the level of quantification (confirmed in at least two consecutive tests).","definition_or_measurement_approach":"Proportion of patients with partial response at 8 weeks who later achieve CMV DNAemia below LOQ (confirmed in ≥2 consecutive tests) within 12 weeks."}
• {"endpoint_text":"- The secondary safety endpoint is to describe the incidence of grade > 2 side effects considered related to maribavir therapy during the treatment period.","definition_or_measurement_approach":"Incidence of grade >2 adverse events considered related to maribavir during treatment period."}

Italy

Earliest CTIS Part Ii Submission Date

22-05-2025

Latest Decision Or Authorization Date

17-11-2025

Processing Time Days

179

Number Of Sites

20

Number Of Participants

81

Primary sponsor

Full Name

Gruppo Italiano Per Il Trapianto Di Midollo Osseo Cellule Staminali Emopoietiche E Terapia Cellulare

Organisation Type

Patient organisation/association

Country Of Registered Address

Italy

Third parties

• {"country":"Italy","full_name":"Fullcro S.r.l.","duties_or_roles":"sponsorDuties codes: 1, 12, 15 (TMF management), 5, 6","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Istituto Di Fisiologia Clinica Del CNR Officina Farmaceutica Dell'Istituto Di Fisiologia Clinica","duties_or_roles":"sponsorDuties code: 10","organisation_type":"Laboratory/Research/Testing facility"}