SIPPET Study on inhibitors in Hemophilia A: interim analysis confirms the original hypothesis


05.02.2015

The Study is safe to continue after Investigators' Meeting and the disclosure of interim analysis in San Francisco (Dec 2014)

San Francisco, February 5, 2015: Relevant updates of the SIPPET Study have been presented during the last SIPPET Investigators' Meeting held in San Francisco in December, on the occasion of the 56th Annual Meeting of the ASH, American Society of Hematology.

As Prof. Flora Peyvandi, Promoter and Study Coordinator, stated: "Recruitment of 300 patients has been achieved and the SIPPET study enrolment will be completed shortly in 14 countries from 4 continents (Europe, America, Asia and Africa). The recruitment and enrolment of new previously untreated patients (PUPs) or minimally treated patients (MTPTs) is now stopped".

The interim analysis has been completed for 205 cases by Prof. Frits Rosendaal, independent researcher at the Leiden University Medical Center, and an interim report has been submitted to the Data Safety Monitoring Board. The members of the Board reviewed the report and three main conclusions have been reported during the Investigator meeting: the SIPPET Study is safe to continue, there is no futility issue to stop the study from continuing, and going forward it is critical to maintain the data in confidence and to keep the integrity of the study.

"With this background – Prof. Rosendaal explained – it's important to underline that the absence of futility means that the original hypothesis of SIPPET of an at least 2-fold lower incidence of FVIII inhibitors with plasma-derived, VWF-containing products is still viable and valid."

SIPPET (Survey on Inhibitors in Plasma-Product Exposed Toddlers) is an investigator-initiated study, international, multicenter, prospective, controlled, randomized and open-label clinical study which aims to test the hypothesis that plasma-derived VWF/FVIII products are less immunogenic than recombinant FVIII products. For this reasons the study compares two classes of products and not two specific products belonging to these classes.

More information on www.sippet.org