A phase 2, multicentric study to assess the efficacy and safety of maribavir treatment in hematopoietic stem cell transplant (HSCT) recipients with cytomegalovirus (CMV) infection with a medical condition that contraindicate the administration of ganciclovir, valganciclovir or foscarnet and in those who discontinued first line preemptive therapy with ganciclovir, valganciclovir or foscarnet due to toxicity or intolerance.

Ki vehet részt

• Allogeneic hematopoietic stem cell transplant performed within previous twelve months
• Absence of diarrhea or other intestinal symptoms or active intestinal pathology
• Life expectancy not severely limited by concomitant illness
• Women of childbearing potential must use highly effective contraception for at least 1 month after the last dose of maribavir
• Willing and able to comply with all of the requirements and visits in the protocol
• ten and signed informed consent
• Diagnosis of CMV infection
• 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
• Age > 18 years
• Weigh ≥40 kg
• Able to swallow tablets
• Performance status: ECOG <3
• Adequate hepatic function (bilirubin ≤2 UNL; ALT/AST ≤2,5 UNL)
• Adequate renal function (creatinine clearance ≥50 ml/min)

Ki nem vehet részt

• 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
• Patients with other life-threatening concurrent disease
• Participation in another clinical trial within 1 month before the start of this trial
• Any active, uncontrolled infection
• End-organ CMV disease
• Subjects with known hypersensitivity to any of the component medication
• Non-cooperative behaviour or non-compliance