The U.S. Food and Drug Administration (FDA) has placed a clinical hold on a phase III clinical trial for REG1due to reports of serious adverse events.
REG1, also known as Revolixys Kit, is a two drug anticoagulant system, that is currently in a suspended phase III trial, called REGULATE-PCI.
According to clinicaltrials.gov, the REG1 phase III study, NCT01848106, started in September 2013 and wanted to recruit 13,200 participants. The FDA clinical hold means that no new participants may be recruited and given REG1 and current participants are prohibited from being given further doses of REG1, until the FDA has decided it is safe to continue the trial.
According to Medscape, the REG1 study was halted by the Data Safety Monitoring Board because of reports of serious adverse events, related to allergic reactions. Forbes reports that 3,234 people had already been enrolled in the REG1 trial.
During the phase 2b trial for REG1, allergic reactions caused participant enrollment in one study arm to be halted. According to the European Heart Journal, the reactions were serious and one participant developed tachycardia and had to be cardioverted back to a normal heart rhythm. No further participants were recruited for this study arm.
Many adverse events have been reported during the five complete clinical trials conducted for REG1, including:
REG1 has been tested in six clinical trials, the last two trials have been halted or partially halted, at medical centers around the country.