Purpose

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.

Condition

Eligibility

Eligible Ages
Over 12 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients >12 years of age with severe or moderate hereditary FX deficiency. Severe is defined as <1 IU/dL and moderate as 1 to 5 IU/dL (3)
  • Patients who have given written informed consent (for sites in the USA this will include the Health Insurance Portability and Accountability Act (HIPAA) authorization statement), OR, in the case of 12-18 year olds, written informed consent from the parents/ guardians and where appropriate assent from the child
  • Patients requiring major surgery. Major surgery is defined as procedures typically requiring:
  • full anesthesia or regional anesthesia, e.g. epidural or spinal and
  • involving the opening of major cavities such as thoracic, abdominal surgery; orthopedic surgery, and Caesarean section (C-section) and
  • requiring at least one overnight stay in hospital (16)

Exclusion Criteria

  • Patients known to be pregnant, unless the surgery is C-section.
  • Patients who participated in a clinical study trial in the last 30 days prior to study enrolment, except if they have been involved in another study involving Coagadex.
  • Patients with a known history of inhibitor development to FX.
  • Patients who are required or expected to take other factor X-containing medications during or after surgery.
  • Patients with existing known thrombocytopenia (platelets < 50 x 109/L).
  • Patients with existing known clinically significant renal disease (creatinine >200 µmol/L).
  • Patients with existing known clinically significant liver disease (ALT levels greater than three times the upper limit of normal).
  • Patients with existing known other coagulopathy or thrombophilia.
  • Patients with a known intolerance or allergy to Coagadex or its excipients.
  • Patients known to have abused chemicals or drugs within the past 12 months.
  • Patients with a history of unreliability or non-cooperation.

Study Design

Phase
Study Type
Observational
Observational Model
Case-Control
Time Perspective
Retrospective

Arm Groups

ArmDescriptionAssigned Intervention
Moderate to Severe Factor X Deficiency
  • Drug: Coagadex
    Plasma-driven blood coagulation factor X concentration
    Other names:
    • Factor X

Recruiting Locations

Tulane University Hospitals and Clinics
New Orleans, Louisiana 70112
Contact:
Melody Benton

More Details

Status
Recruiting
Sponsor
Bio Products Laboratory

Study Contact

Belinda Hereghty
919-354-8395
belinda.hereghty@bplgroup.com

Detailed Description

The primary objective is to collect additional surgical data on the clinical effectiveness of Coagadex, in a post-marketing environment, for peri-operative hemostatic cover during major surgery in patients with moderate or severe hereditary factor X (FX) deficiency.

The secondary objective is to review safety data on Coagadex through the collection of any Adverse Drug Reactions (ADRs) from the first dose of Coagadex in the hospital prior to the surgical procedure until the first follow-up after discharge (i.e., follow-up completed) and Serious ADRs up until the post-operative care follow-up has been completed. Data on any deaths and pregnancies reported within this time period will be collected.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.