A extremely promising novel anticoagulant method now appears to be in serious issues. Regado Biosciences announced these days that the FDA had positioned a “clinical hold” on patient enrollment and dosing in the REGULATE-PCI trial, which is testing the Revolixys anticoagulation technique. Revolixys consists of the Factor IX inhibitor pegnivacogin and an agent, anivamersen, which reverses its anticoagulant result.
REGULATE-PCI is a phase 3 trial evaluating Revolixys to bivalirudin (Angiomax, The Medicines Firm) in 13,000 patients undergoing PCI. The principal investigators of the trial are A. Michael Lincoff (Cleveland Clinic), Roxana Mehran (Mount Sinai), and John Alexander (Duke Clinical Investigation Institute).
The FDA action is not fully unexpected. On July 2 the company announced that patient enrollment in the trial had been paused when the Data Safety Monitoring Board (DSMB) initiated an unplanned assessment of trial data. The company explained the DSMB would “conduct a full evaluation of security and treatment advantage-danger ratio of all individuals enrolled to date (3234) with a emphasis on significant adverse occasions connected to allergic reactions.”
Regado mentioned the clinical hold was taken by the FDA “to formalize the involvement of the FDA in any selection to re-initiate enrollment and dosing in the trial in the future.” The organization CEO stated that “any recommendation to re-initiate patient enrollment in REGULATE-PCI will be based mostly on the DSMB’s conclusions and would constantly be implemented in agreement with FDA.” The two the firm and the trial’s principal investigators stay blinded to the examine benefits.
FDA Areas Clinical Hold On Phase 3 Trial Of Novel Anticoagulant
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