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

NCT ID: NCT03161626

Last Updated: 2021-11-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 3 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-02-27
• Study Completion Date: 2021-10-13

Brief 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.

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.

Conditions

Factor 10 Deficiency

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Moderate to Severe Factor X Deficiency

Coagadex

Intervention Type: DRUG

Plasma-driven blood coagulation factor X concentration

Interventions

Coagadex

Plasma-driven blood coagulation factor X concentration

Intervention Type: DRUG

Other Intervention Names

Factor X

Eligibility Criteria

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.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bio Products Laboratory

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Florida Health

Gainesville, Florida, United States

Tulane University Hospitals and Clinics

New Orleans, Louisiana, United States

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Countries

United States

Other Identifiers

Ten06

Identifier Type: -

Identifier Source: org_study_id