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RECRUITING Phase 3

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

NCT06963216 · View on ClinicalTrials.gov ↗

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

Sponsor

Kedrion S.p.A.

31 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06963216

The ClinicalTrials.gov registry entry for NCT06963216 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kedrion S.p.A., which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06963216 reports 3 study locations spanning 3 distinct geographic areas — top geographies include Arizona, Minnesota, London. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06963216?

The interventions under investigation include: Coagadex(R) (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06963216?

This trial is sponsored by Kedrion S.p.A., which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial