Omrix Completes Enrollment of 90 Patients in Phase II Fibrin Pad Trial
Posted on: Wednesday, 24 September 2008, 09:00 CDT
Omrix Biopharmaceuticals, a fully-integrated biopharmaceutical company, has completed enrollment of the first 90 patients in its Phase II clinical trial for the Fibrin Pad in mild to moderate bleeding. The company expects to release 90 patient interim efficacy analysis by the end of October 2008.
The Fibrin Pad is said to be a breakthrough convergence product being developed by Omrix in collaboration with Ethicon, a Johnson & Johnson company. The Phase II clinical trial is a randomized, controlled clinical study in soft tissue to evaluate the superiority of the Fibrin Pad when compared to Surgicel.
The primary endpoint will measure time to hemostasis at four minutes after randomization and if any re-bleeding occurs during a subsequent six minute observation period. The first 90 patients were randomized two to one so that 60 patients have been treated with the Fibrin Pad and 30 patients have been treated with Surgicel.
The interim efficacy analysis is being conducted to assess the superiority of the Fibrin Pad when compared to Surgicel. If the interim analysis demonstrates superiority, the study will continue as an open label study and will enroll an additional 40 patients. Of the 130 total patients enrolled in the study, 100 will be treated with the Fibrin Pad as required by the study protocol. All 130 patients are expected to be enrolled by the end of 2008 or early 2009.
The study protocol provides for the enrollment of up to 210 patients. In the event that the interim analysis from the first 90 patients does not show superiority, the study will continue with two to one randomized enrollment in increments of 30 patients. The company would then assess superiority after each 30 patient increment.
The company anticipates that if additional enrollment is required, then the study will be extended by several months for each additional block of 30 patients needed to demonstrate superiority.
Source: Datamonitor
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