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Completed

NCT Number: NCT01489111

Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.

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.

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Key information

Conditions

Congenital Bleeding Disorder Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Haemophilia A Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia A Hemorrhagic Disorders

Age range

12 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Camperdown, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Turoctocog alfa pegol

Drug

Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.

Other names: NNC 0129-0000-1003

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A

Acronym: pathfinder™3

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Dec 9, 2011
Registry last updated
Aug 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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