Title
Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
A Randomized, Double-blind, Placebo Controlled Trial to Evaluate the Safety, Tolerability and Antiviral Activity of 12 Weeks' Treatment With a New Antiviral HCMV Drug
Phase
Phase 2Lead Sponsor
AiCuris Anti-infective Cures GmbHStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
HCMV Reactivation or HCMV End-Organ DiseaseIntervention/Treatment
letermovir ...Study Participants
133The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).
Oral administration
Oral administration
Oral administration
Oral administration
Inclusion Criteria: Seropositive for HCMV IgG antibodies before transplantation First allogeneic Human blood precursor cell (HBPC) transplantation performed for 1 of the following diagnoses: leukaemia, lymphoma, Hodgkin's lymphoma, non-Hodgkin's lymphoma, multiple myeloma, myelodysplastic and myeloproliferative disorder Evidence of post transplantation engraftment Able to swallow tablets. Exclusion Criteria: Previous anti-HCMV therapy after this allogeneic HBPC transplantation Mismatched or cord blood transplant recipients Current or history of end-organ HCMV disease Graft versus host disease (GVHD) Impaired liver function Reduced renal function
| Event Type | Organ System | Event Term | AIC246 (60 mg) | AIC246 (120 mg) | AIC246 (240 mg) | Placebo |
|---|
