REVERSE-IT Trial
Research type
Research Study
Full title
A Phase 3, Multicenter, Open-Label, Single-Arm Study of PB2452 in Ticagrelor-Treated Patients with Uncontrolled Major or Life-Threatening Bleeding or Requiring Urgent Surgery or Invasive Procedure (REVERSE-IT Trial)
IRAS ID
289124
Contact name
Robert Storey
Contact email
Sponsor organisation
SFJ Pharmaceuticals, Inc.
Eudract number
2019-004457-92
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, months, days
Research summary
The aim of this study is to see if an investigational drug (PB2452) can reverse the effects of another drug called ticagrelor. Ticagrelor is an anti-platelet drug and helps prevent platelets (cells in the blood) from clumping and forming clots. The purpose of this study is to see if PB2452 is safe, and will reverse the bleeding effects of ticagrelor in patients who need urgent surgery or are having uncontrolled bleeding. Currently, there are no approved drugs or treatments available to reverse the anti-platelet effects of ticagrelor.
The study will consist of a Screening/Pre-treatment period, an on-site assignment to study treatment and administration, a Follow-up visit and a Final Follow-up visit. Infusion of PB2452 will be initiated on Day 1 and will continue for approximately 16 hours.
Approximately 200 patients are being targeted to participate in this study across Europe, North America and Asia Pacific.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
20/NE/0262
Date of REC Opinion
22 Dec 2020
REC opinion
Further Information Favourable Opinion