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
Kedrion S.p.A.
Summary
The purpose of this study is to evaluate the efficacy and safety of Coagadex in treating active bleeds and to manage peri-operative bleeding in participants with acquired factor X deficiency associated with AL amyloidosis.
Description
This study is designed to evaluate the efficacy and safety of Coagadex® in treating active bleeds and to manage peri-operative bleeding in participants with aFXD associated with AL amyloidosis. Coagadex® is a plasma-derived human coagulation factor concentrate expected to treat bleeding episodes in patients with aFXD associated with AL amyloidosis by delivering concentrated Factor X to address the clotting deficiency caused by the disease. aFXD is a rare condition (prevalence of \<1 / 1 000 000 \[Orphanet 2024\]) and may occur due to infections, neoplastic and chronic diseases (Lee G et al.,…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Male or female participants ages 18-70 years old. 2. Diagnosis of aFXD associated with AL amyloidosis with FX:C ≤ 50 IU/dL. 3. Woman of Childbearing Potential (defined in Appendix 2) and men of reproductive potential who agree to use an effective contraception measure during the study. Exclusion Criteria: 1. Female participants that are pregnant or lactating. 2. Presence of FX inhibitors. 3. Uncontrolled arterial hypertension. 4. On anticoagulant therapy (not antiplatelets), unstable heart disease, clinically significant thrombotic event in the past 180 days or any ot…
Interventions
- BiologicalCoagadex(R)
Coagulation Factor X (Human)
Locations (3)
- Mayo Clinic ArizonaPhoenix, Arizona
- Mayo Clinic RochesterRochester, Minnesota
- Cancer Clinical Trials UnitLondon, London