FDA Clinical Hold on REG1/Revolixys Kit Phase III Trial
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 Trial On Suspension Until Further Notice
On July 9, 2014, Regado Biosciences announced that the FDA had put a clinical hold on their REG1 phase III clinical trial.
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.
Allergic Reactions Halted REG1 Phase 2b 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.
REG1 Side Effects Seen In Clinical Trials
Many adverse events have been reported during the five complete clinical trials conducted for REG1, including:
- Transient Encephalopathy
- Minor Bleeding
- Cutaneous Reactions(rash)
- Blood in Stool
- Allergic-like Reactions
- Major Gastrointestinal Bleeding
- Major Bleeding
- Dyspnoea (shortness of breath)
- Urticaria (hives)
REG1 Trials : Locations and Participant Numbers
REG1 has been tested in six clinical trials, the last two trials have been halted or partially halted, at medical centers around the country.
- Phase 1a : 85 participants in Bethesda, MD (June-October 2005)
- Phase 1b : 50 participants at seven sites (April 2006- March 2007)
- Anchorage, AK; Rapid City, SD; Lexington, KY; Hershey, PN; Houston, TX; New York City, NY; Atlanta, GA
- Phase 1c : 39 participants at one site
- Phase 2a : 26 participants at five locations (October 2007 – October 2008)
- Indianapolis, IN; Detroit, MI; Chapel Hill, NC; Danville, PN; Rapid City, SD
- Phase 2b : 640 participants at 26 locations (September 2009 – November 2010)
- Huntsville, AL; Sacramento, CA; San Diego, CA; Clearwater, FL; Gainsville, FL; Fort Lauderdale, FL; Jacksonville, FL; Gainesville, GA; Boise, ID; Meridian, ID; Chicago, Il; Indianapolis, In; Houma, La; Baltimore, MD; Detroit, MI; Buffalo, NY; Chapel Hill, NC; Cincinnati, OH; Philadelphia, PN; Rapid City, SD; Cypress, TX; Seattle, WA; Spokane, WA; Milwaukee, WI
- Phase 3 : 3,234 participants, enrolled before trial halted, (September 2013 – present)