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news.Omrix Biopharmaceuticals, a developer of biosurgical and immunotherapy products, has announced that the fibrin pad US Phase II clinical trial in mild to moderate bleeding will resume patient enrollment and continue with no modifications.
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Previously, the company announced that the US Phase II clinical trial had been suspended in order to investigate an incident of post-operative bleeding. This event met the stopping rules, as outlined in the clinical trial protocol.
Per the clinical trial protocol, upon the suspension of the study, a data safety monitoring board (DSMB) reviewed the data related to the event. The DSMB has concluded their investigation and authorized the trial to recommence.
According to Omrix, the fibrin pad builds on the company’s aprotinin-free fibrin sealant technology incorporated into Evicel fibrin sealant. The fibrin pad is said to be designed for the management and rapid control of mild, moderate and severe bleeding.