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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03161626
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Bio Products Laboratory

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.

Condition or disease Intervention/treatment
Factor 10 Deficiency Drug: Coagadex

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.


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Study Type : Observational
Estimated Enrollment : 3 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021


Group/Cohort Intervention/treatment
Moderate to Severe Factor X Deficiency Drug: Coagadex
Plasma-driven blood coagulation factor X concentration
Other Name: Factor X




Primary Outcome Measures :
  1. Retrospective surgical data collection [ Time Frame: 12 months ]
    Blood loss (mL)



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with moderate or severe hereditary Factor X deficiency undergoing major surgery.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03161626


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

Locations
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United States, Louisiana
Tulane University Hospitals and Clinics Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Melody Benton         
Principal Investigator: Tammuella Singleton, MD         
United States, Michigan
West Michigan Cancer Center Recruiting
Kalamazoo, Michigan, United States, 49007
Contact: Nancy Inverso, R.N.         
Principal Investigator: Mitchell Berger, MD         
Sponsors and Collaborators
Bio Products Laboratory
Investigators
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Principal Investigator: Liz Holmes, MD Bio Products Laboratory

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Responsible Party: Bio Products Laboratory
ClinicalTrials.gov Identifier: NCT03161626     History of Changes
Other Study ID Numbers: Ten06
First Posted: May 22, 2017    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Factor X Deficiency
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn