Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients

Summary

The 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).

Timeline

Start

2010-03

Primary completion

2011-10

Completion

2011-12

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

paper The incidence of prophylaxis failure with letermovir, as compared with placebo, was 48% versus 64% at a daily letermovir dose of 60 mg (P=0.32) reads as mixed primary results PMID 24806159 ↗

paper 32% at a dose of 120 mg (P=0.01), and 29% at a dose of 240 mg (P=0.007). reads as mixed primary results PMID 24806159 ↗

paper Kaplan-Meier time-to-onset profiles for prophylaxis failure showed a significant difference in the comparison of letermovir at a dose of 240 mg reads as mixed primary results PMID 24806159 ↗

release “letermovir in HCMV-seropositive allogeneic human blood precursor cell recipients (bone marrow transplant patients) met all primary efficacy endpoints.” reads as met primary endpoint merck.com ↗

Publications

• Chemaly RF, Ullmann AJ, Stoelben S, Richard MP, Bornhauser M, Groth C, Einsele H, Silverman M, Mullane KM, Brown J, Nowak H, Kolling K, Stobernack HP, Lischka P, Zimmermann H, Rubsamen-Schaeff H, Champlin RE, Ehninger G; AIC246 Study Team. Letermovir for cytomegalovirus prophylaxis in hematopoietic-cell transplantation. N Engl J Med. 2014 May 8;370(19):1781-9. doi: 10.1056/NEJMoa1309533.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Letermovir	Small molecule	60 mg	Oral
Subject	Letermovir	Small molecule	120 mg	Oral
Subject	Letermovir	Small molecule	240 mg	Oral

Indications