New hope for rare bleeding disorder: coagadex trial targets AL amyloidosis
NCT ID NCT06963216
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This phase 3 study tests Coagadex, a human clotting factor X, in 15 adults with acquired factor X deficiency caused by AL amyloidosis. The goal is to see if it safely stops active bleeding and helps manage bleeding during surgery. Participants receive the drug on demand for bleeds or before procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Coagadex (human coagulation factor X)
- What this could lead to
- If successful, this could provide a safe and effective treatment to control bleeding episodes in people with this rare condition.
- What could go wrong
- This is a small, early-stage trial with only 15 participants, so results may not apply to everyone. The treatment is for managing bleeding, not curing the underlying disease.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Finished
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Jun 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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