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Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A. (pathfinder™3)

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ClinicalTrials.gov Identifier: NCT01489111
Recruitment Status : Completed
First Posted : December 9, 2011
Results First Posted : January 21, 2020
Last Update Posted : August 10, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A Drug: turoctocog alfa pegol Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A
Actual Study Start Date : August 3, 2012
Actual Primary Completion Date : December 10, 2018
Actual Study Completion Date : December 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Experimental: Surgery Drug: turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
Other Name: NNC 0129-0000-1003




Primary Outcome Measures :
  1. Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None [ Time Frame: Assessed by the Investigator/surgeon at the day of surgery ]

    Haemostatic effect during surgery was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'. This was assessed after completion of surgery (defined as "last stitch").

    Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.

    None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.



Secondary Outcome Measures :
  1. Average Consumption of N8-GP During Surgery [ Time Frame: During surgery, defined as the time from "knife to skin" until "last stitch" ]
    Average consumption of N8-GP, during surgery is presented. The time during surgery is defined from 'knife to skin' until 'last stitch'.

  2. Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6 [ Time Frame: During the post-operative period, days 1-6 ]

    Haemostatic effect during post-operative period days 1-6 as evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'.

    Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.

    None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.


  3. Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14 [ Time Frame: During the post-operative period, days 7-14 ]

    Haemostatic effect during post-operative period days 1-6 and days 7-14 was evaluated on a four-point response scale as 'none', 'moderate', 'good' and 'excellent'.

    Excellent: Better than expected/predicted in this type of procedure. Good: As expected in this type of procedure. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen.

    None: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.


  4. Average Consumption of N8-GP During the Post-operative Period Days 1-6 [ Time Frame: During the post-operative period, days 1-6 ]
    Average consumption of N8-GP during post operative period days 1-6 is presented. Analysis population: Full analysis set included all subjects exposed to the trial drug (N8-GP) and completed surgery.

  5. Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL) [ Time Frame: during the trial (2-5 weeks) ]
    Incidence rate of inhibitors is the number of newly developed inhibitors per surgery. Development of FVIII inhibitors was measured by a validated Nijmegen modified Bethesda assay. A positive inhibitor test was defined as ≥0.6 bethesda unit. Number of participants with inhibitors at the end of trial is presented.

  6. Estimated Blood Loss During Surgery [ Time Frame: During surgery ]
    The mean estimated blood loss following surgery is presented. Estimated blood loss (mL) was evaluated post surgery.

  7. Number of Transfusions During the Post-operative Period Days 1-6 [ Time Frame: Post-operative period, days 1-6 ]
    Number of blood product transfusions (transfusion of red blood cells) during the post-surgery period, Days 1-6 is presented.

  8. Length of Stay in the Hospital [ Time Frame: During the trial (2-5 weeks) ]
    Mean number of days stayed at the hospital during the trial.

  9. Number of Days in Intensive Care [ Time Frame: During the trial (2-5 weeks) ]
    Mean number of days in the intensive care due to surgery during the trial is presented.

  10. Adverse Events Reported During the Trial Period [ Time Frame: During the trial (2-5 weeks) ]
    Number of adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14).

  11. Serious Adverse Events Reported During the Trial Period [ Time Frame: During the trial (2-5 weeks) ]
    Number of serious adverse event during the trial is presented. This includes events from the first trial related activity after the patient has signed the informed consent and until the end of trial (earliest at day 14).



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject.)
  • Ongoing participation in the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial and having received greater than or equal to 5 doses of N8-GP
  • Undergoing major surgery requiring daily monitoring of FVIII:C (FVIII activity) and wound status for at least 3 days
  • The patient and/or Legally Acceptable Representative (LAR) is capable of assessing a bleeding episode, keeping an eDiary, capable of home treatment of bleeding episodes and otherwise capable of following the trial procedures

Exclusion Criteria:

  • Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
  • Previous withdrawal from the pathfinder™2 (NN7088-3859) or the pathfinderTM 4 (NN7088-3861) trial after administration of trial product, except interruption due to inclusion in this pathfinderTM 3 trial (NN7088-3860)
  • The receipt of any investigational medicinal product (except N8-GP) within 30 days prior to enrolment into the trial. (For Brazil, only: Participation in a previous clinical trial within one year prior to screening for this trial (Visit 1), unless there is a direct benefit to the research subject, at the Investigator's discretion)
  • FVIII inhibitors at least 0.6 BU (Bethesda Units)/mL at screening
  • Previous arterial thrombotic events (e.g. myocardial infarction and intracranial thrombosis) or previous deep venous thrombosis or pulmonary embolism (as defined by available medical records)
  • Immune modulating or chemotherapeutic medication
  • Any disease (liver, kidney, inflammatory and mental disorders included) or condition which, according to the Investigator's judgement, could imply a potential hazard to the patient, interfere with trial participation or trial outcome
  • Unwillingness, language or other barriers precluding adequate understanding and/or 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): NCT01489111


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  Study Documents (Full-Text)

Documents provided by Novo Nordisk A/S:
Additional Information:
Publications of Results:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01489111    
Other Study ID Numbers: NN7088-3860
U1111-1119-7326 ( Other Identifier: WHO )
2011-001144-30 ( EudraCT Number )
132215 ( Other Identifier: JapicCTI )
First Posted: December 9, 2011    Key Record Dates
Results First Posted: January 21, 2020
Last Update Posted: August 10, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Hemostatic Disorders
Hemophilia A
Blood Coagulation Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Vascular Diseases
Cardiovascular Diseases