Efficacy Study of Human Cytomegalovirus (HCMV) Hyperimmune Globulin to Prevent Congenital HCMV Infection

Phase 2/3 Completed 124 enrolled Fondazione IRCCS Policlinico San Matteo di Pavia

RandomizedParallel-groupQuadruple-blindPrevention

Summary

The aim of this trial is to verify, under controlled conditions, the reported efficacy of human cytomegalovirus (HCMV)-specific hyperimmune globulin administration to pregnant women suffering from primary HCMV infection for the prevention of intrauterine HCMV transmission.

Timeline

Start: 2009-06
Primary completion: 2011-10
Completion: 2011-10

Outcome

Missed primary endpoint

paper a difference of 14 percentage points; 95% confidence interval, -3 to 31; P=0.13). PMID 24693891 ↗

paper treatment with hyperimmune globulin did not significantly modify the course of primary CMV infection during pregnancy. PMID 24693891 ↗

Publications

Revello MG, Lazzarotto T, Guerra B, Spinillo A, Ferrazzi E, Kustermann A, Guaschino S, Vergani P, Todros T, Frusca T, Arossa A, Furione M, Rognoni V, Rizzo N, Gabrielli L, Klersy C, Gerna G; CHIP Study Group. A randomized trial of hyperimmune globulin to prevent congenital cytomegalovirus. N Engl J Med. 2014 Apr 3;370(14):1316-26. doi: 10.1056/NEJMoa1310214.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cytogam	Protein / enzyme biologic	100 iu/kg	Intravenous