NCT06963216WithdrawnPhase 3
A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis
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
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 14 Apr 2025
- Start date
- Jun 2026
- Primary completion date
- 10 Jun 2026
- Lead sponsor
- Kedrion S.p.A.
- Diseases
- Amyloidosis
- NCT number
- NCT06963216
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of FX inhibitors.
- Participation in another interventional clinical study with an investigational drug, biologic, or device within 30 days prior to screening.
- Hemodynamically unstable due to any cause or even after blood transfusion, fluid resuscitation and pharmacologic or volume replacement pressor therapy.
- Prior history of bleeding disorder other than aFXD.
Other illness
- Uncontrolled arterial hypertension.
- 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.
Other
- Female participants that are pregnant or lactating.
- Any factor X containing product taken within 2 weeks of first Coagadex® administration.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.