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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

Tracking Information
First Submitted Date May 18, 2017
First Posted Date May 22, 2017
Last Update Posted Date March 19, 2019
Actual Study Start Date February 27, 2018
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2017)
Retrospective surgical data collection [ Time Frame: 12 months ]
Blood loss (mL)
Original Primary Outcome Measures
 (submitted: May 18, 2017)
Surgical narrative data for each patient [ Time Frame: 12 months ]
Data summaries
Change History Complete list of historical versions of study NCT03161626 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery
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
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.

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with moderate or severe hereditary Factor X deficiency undergoing major surgery.
Condition Factor 10 Deficiency
Intervention Drug: Coagadex
Plasma-driven blood coagulation factor X concentration
Other Name: Factor X
Study Groups/Cohorts Moderate to Severe Factor X Deficiency
Intervention: Drug: Coagadex
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 18, 2017)
3
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2021
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Belinda Hereghty 919-354-8395 belinda.hereghty@bplgroup.com
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03161626
Other Study ID Numbers Ten06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bio Products Laboratory
Study Sponsor Bio Products Laboratory
Collaborators Not Provided
Investigators
Principal Investigator: Liz Holmes, MD Bio Products Laboratory
PRS Account Bio Products Laboratory
Verification Date March 2019