A Phase III Open-Label study of Coagadex in Adults with aFXD associated with AL amyloidosis
Research type
Research Study
Full title
A Phase III Open-Label Multi-Center Study of the Pharmacokinetics, Safety, and Efficacy of Coagadex in the Treatment of Adults with Acquired Factor X Deficiency Associated with Light Chain Amyloidosis.
IRAS ID
1011593
Contact name
Cecilia Conz
Contact email
Sponsor organisation
Kedrion S.p.A.
Clinicaltrials.gov Identifier
Research summary
This study will look at a medicine called Coagadex to find out how it is absorbed by and removed from the body, if it is safe for use, and if it works for adult patients who lack a protein called Factor X and have a disease called light-chain (AL) amyloidosis.
People who lack Factor X may have difficulties in stopping bleeding in case of trauma or surgery and may have spontaneous blood loss inside the body. AL amyloidosis is a disease where the body
produces a type of abnormal protein which gathers in large amounts in organs. In this study you will be divided into 2 groups, one group who may bleed spontaneously and one group who may bleed because they need some type of surgical intervention.
The study team will run some tests on patients in each group, give them Coagadex as an intravenous (IV) infusion to replace the low Factor X and run more tests after to see how the medicine is absorbed and cleared, if it is safe and if it stops the bleeding. Once the study has ended, you will not be able to continue to receive Coagadex, and you will return to standard care. Your Study Doctor will discuss standard care treatment options with you.REC name
South Central - Oxford B Research Ethics Committee
REC reference
25/SC/0195
Date of REC Opinion
22 Jul 2025
REC opinion
Further Information Favourable Opinion