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
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Male or female participants ages 18-70 years old.
• Diagnosis of aFXD associated with AL amyloidosis with FX:C ≤ 50 IU/dL.
• Woman of Childbearing Potential (defined in Appendix 2) and men of reproductive potential who agree to use an effective contraception measure during the study.
Locations
United States
Arizona
Mayo Clinic Arizona
RECRUITING
Phoenix
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
Contact Information
Primary
Nicola Rovai
n.rovai@kedrion.com
+39 335 6524750
Time Frame
Start Date: 2026-02
Estimated Completion Date: 2027-09
Participants
Target number of participants: 15
Treatments
Experimental: On-Demand Treatment Cohort
Participants without an active bleeding event will enter the Run-In Period, which lasts up to 180 days. Upon a bleeding event participants will receive a first dose of 40 IU/kg of Coagadex®. Additional dose(s) will be based on the incremental recovery (IR). (If an allowed Emergent Surgery becomes necessary in the Run-In Period, the participant will cross over into the Surgery/Invasive Procedures Cohort.)
Experimental: Surgery/Invasive Procedures Cohort
Participants enrolled at least 3 weeks prior to a scheduled surgical intervention will undergo pharmacokinetic sampling. The dose of Coagadex® will be determined based on the patient's PK profile. (During this 3-week period, if the participant develops an acute bleed, they will cross over into the On-Demand Treatment Cohort for treatment.)
Related Therapeutic Areas
Sponsors
Collaborators: Worldwide Clinical Trials
Leads: Kedrion S.p.A.