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NCT06963216 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Acquired Factor X Deficiency, sponsored by Kedrion S.p.A..

Recruiting
Registry status
Phase 3
Development phase
15
Enrollment target
3
Study locations

NCT06963216: Recruiting Phase 3 study of Acquired Factor X Deficiency, sponsored by Kedrion S.p.A..

NCT06963216 is a Phase 3 study of Acquired Factor X Deficiency that is actively recruiting participants, run by Kedrion S.p.A.. The registered enrollment target is 15 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06963216, a Phase 3 study of Acquired Factor X Deficiency, is actively recruiting participants, sponsored by Kedrion S.p.A..

RECRUITING
Registry status
Phase 3
Development phase
15 participants
Enrollment target
3
Study locations

Study 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.

Interventions

  • BIOLOGICAL Coagadex(R)

Study Locations (3)

Arizona

  • Mayo Clinic Arizona - Phoenix

Minnesota

  • Mayo Clinic Rochester - Rochester

London

  • Cancer Clinical Trials Unit - London

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2026-02
Est. Completion 2027-09
Phase Phase 3
Kedrion S.p.A.

8 total trials

What NCT06963216 shows while recruiting

NCT06963216 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).

The record links to 1 condition, with Acquired Factor X Deficiency appearing as the primary indexed condition, and to 1 intervention - of which Coagadex(R) is the first listed.

NCT06963216 reports a single indexed study location in Arizona, Minnesota, London.

Frequently Asked Questions

What is clinical trial NCT06963216 about?

NCT06963216 is a clinical study titled "A Study Investigating Coagadex in the Treatment AFXD Associated With AL Amyloidosis". 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.

What is the current status of trial NCT06963216?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 15 participants. The study started on 2026-02. Estimated completion is 2027-09.

What conditions does trial NCT06963216 study?

This clinical trial studies the following conditions: Acquired Factor X Deficiency.

What interventions are being tested in trial NCT06963216?

The interventions under investigation include: Coagadex(R) (BIOLOGICAL).

Who is sponsoring clinical trial NCT06963216?

This trial is sponsored by Kedrion S.p.A., which has 8 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06963216 being conducted?

This trial has 3 study locations across Arizona, Minnesota, London. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT06963216's enrollment target sits among peer trials

15 1978th of 2000 higher than 18 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06963216, the US trial registry maintained by the National Library of Medicine. NCT06963216 (small enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.