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

NCT03161626 | Completed FDA Drug

• 1 other identifier: Ten06
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 3

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.

Conditions

Factor 10 Deficiency

Outcome Measures

Primary Outcomes (1)

• Retrospective surgical data collection

  Blood loss (mL)

  12 months

Study Arms (1)

Moderate to Severe Factor X Deficiency

Drug: Coagadex

Interventions

Coagadex DRUG

Plasma-driven blood coagulation factor X concentration

Also known as: Factor X

Moderate to Severe Factor X Deficiency

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate or severe hereditary Factor X deficiency undergoing major surgery.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bio Products Laboratory: lead

Study Sites (3)

University of Florida Health

Gainesville, Florida, 32610, United States

Location

Tulane University Hospitals and Clinics

New Orleans, Louisiana, 70112, United States

Location

West Michigan Cancer Center

Kalamazoo, Michigan, 49007, United States

Location

MeSH Terms

Conditions

Factor X Deficiency

Interventions

Factor X

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Enzyme Precursors; Enzymes and Coenzymes; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Protein Precursors; Biological Factors

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: May 22, 2017
• Study Start: February 27, 2018
• Primary Completion: October 13, 2021
• Study Completion: October 13, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-11

Locations

US (3)