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

Factor 10 Deficiency Clinical Trial

Official title:

A Multicenter, Post-Marketing Registry Study of COAGADEX® in the Peri-operative Management of Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161626
• Other study ID #: Ten06
• Status: Completed
• Start date: February 27, 2018
• Est. completion date: October 13, 2021

Study information

• Verified date: November 2021
• Source: Bio Products Laboratory
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: October 13, 2021
• Est. primary completion date: October 13, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Factor 10 Deficiency
• Factor X Deficiency

Intervention

Drug:
• Coagadex
Plasma-driven blood coagulation factor X concentration

Locations

Country	Name	City	State
United States	University of Florida Health	Gainesville	Florida
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Tulane University Hospitals and Clinics	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Bio Products Laboratory

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Retrospective surgical data collection	Blood loss (mL)	12 months