SHP620-302

A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Recipients (HSCT)

Treatment

• Experimental arm: 400 mg maribavir/placebo orally twice daily
• Active comparator arm: 900 mg Valganciclovir/placebo orally twice daily

Inclusion criteria

• 16 years of older
• Recipient of hematopoietic stem cell transplant
• Documented asymptomatic CMV infection, with a screening value of CMV DNA ≥ 2730 IU/mL to ≤ 273000 IU/mL in whole blood or ≥ 910 IU/mL to ≤91000 IU/mL in plasma in 2 consecutive assessments, separated by at least 1 day
•  Current CMV infection as the first episode of CMV viremia after HSCT, either primary or reactivation

Exclusion criteria

• CMV tissue invasive disease
• CMV infection that is known to be genotypically resistant to ganciclovir, valganciclovir, foscarnet, or cidofovir based on documented evidence
• Be presenting with recurrent CMV infection
• Require ganciclovir, valganciclovir, foscarnet, or cidofovir administration for conditions other than CMV when study treatment is initiated or would need a co-administration with maribavir for CMV infection.
• Be receiving leflunomide, or artesunate when study treatment is initiated
• Be on treatment with anti-CMV agents (ganciclovir, valganciclovir, foscarnet or cidofovir) for the current CMV infection for longer than 72 hours

Participating sites

• Universitair Ziekenhuis Antwerpen (UZA)
• Institute Jules Bordet
• Cliniques Universitaires UCL Saint-Luc
• Ghent University Hospital
• University Hospital Leuven Gasthuisberg
• AZ Sint Jan Brugge-Oostende
• CHU de Liège