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

NCT06963216 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-05-11

No results posted yet for this 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.

Conditions

  • Acquired Factor X Deficiency

Interventions

BIOLOGICAL

Coagadex(R)

Coagulation Factor X (Human)

Sponsors & Collaborators

  • Kedrion S.p.A.

    lead INDUSTRY

Principal Investigators

  • Mirella Calcinai, MD · Medical Director, Clinical Development

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-06-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06963216 on ClinicalTrials.gov