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Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery

NCT03161626 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2021-11-12

No results posted yet for this study

Summary

This is a non-interventional, multicenter, post-marketing registry study in three patients with moderate or severe hereditary FX deficiency, to assess Coagadex administered peri-operatively for hemostatic cover in major surgery during routine post-marketing use.

Conditions

  • Factor 10 Deficiency

Interventions

DRUG

Coagadex

Plasma-driven blood coagulation factor X concentration

Sponsors & Collaborators

  • Bio Products Laboratory

    lead OTHER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-27
Primary Completion
2021-10-13
Completion
2021-10-13
FDA Drug
Yes

Countries

  • United States

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 NCT03161626 on ClinicalTrials.gov