Assessment GI blood loss after receiving Aspirin or Aspirin plus Rivaroxaban or FXI Inhibitor
Research type
Research Study
Full title
A PARALLEL GROUP STUDY IN HEALTHY PARTICIPANTS TO QUANTITATE INCREASES IN SUBCLINICAL GASTROINTESTINAL BLOOD LOSS FOLLOWING ADMINISTRATION OF ASPIRIN ALONE OR IN COMBINATION WITH RIVAROXABAN OR FACTOR XI INHIBITORS (REGN9933 OR REGN7508)
IRAS ID
1010293
Contact name
Lori Khrimian
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
Research summary
This study is researching experimental drugs called REGN9933 and REGN7508 (called “study drugs”) and comparing their effects to approved treatments of rivaroxaban and aspirin (called “standard treatments”). Aspirin will be given alone or in combination with the study drugs or the other standard treatments to look at their effects on blood loss in the intestines.
The aim of the study is to see if the study drugs REGN9933 and REGN7508, when taken with aspirin, cause less minor intestinal bleeding than standard treatments rivaroxaban with aspirin.
The study is looking at several other research questions, including:
• What side effects may happen from taking the study drug
• How much study drug is in the blood at different times
• Whether the body makes antibodies against the study drug (which could make the drug less effective or could lead to side effects)REC name
London - Hampstead Research Ethics Committee
REC reference
24/LO/0497
Date of REC Opinion
4 Sep 2024
REC opinion
Further Information Favourable Opinion