A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis

Launched by KEDRION S.P.A. · May 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Coagadex to understand how well it works in treating bleeding problems for people who have a condition known as acquired factor X deficiency (aFXD) related to AL amyloidosis. The trial aims to see if Coagadex can help control active bleeding and manage bleeding during surgeries.

To participate, individuals must be between the ages of 18 and 70 and have been diagnosed with aFXD, which means their factor X levels are lower than normal. Women who can become pregnant and men who can father children must agree to use effective birth control during the study. However, there are some people who cannot join, including pregnant or breastfeeding women and those with certain health issues that could complicate the study. Participants will be monitored closely throughout the trial to assess the safety and effectiveness of the treatment. This study is currently not recruiting, so it hasn’t started yet.

Gender

ALL

Eligibility criteria

• 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 other condition that the Investigator believes is likely to interfere with evaluation of the study drug or with satisfactory conduct of the trial.
• • 5. Any factor X containing product taken within 2 weeks of first Coagadex® administration.
• • 6. Participation in another interventional clinical study with an investigational drug, biologic, or device within 30 days prior to screening.
• • 7. Hemodynamically unstable due to any cause or even after blood transfusion, fluid resuscitation and pharmacologic or volume replacement pressor therapy.
• • 8. Prior history of bleeding disorder other than aFXD.