Have you or your loved ones been diagnosed with congenital bleeding disorder?
You may be eligible to participate in a congenital bleeding disorder clinical trial.
Have you or your loved ones been diagnosed with congenital bleeding disorder? You may be eligible to participate in a congenital bleeding disorder clinical trial.
What is a clinical trial? Is participating in a clinical trial right for you? Learn more
Congenital Bleeding Disorder Clinical Trial
Have you or your loved ones been diagnosed with congenital bleeding disorder?
You may be eligible to participate in a congenital bleeding disorder clinical trial.
Have you or your loved ones been diagnosed with congenital bleeding disorder? You may be eligible to participate in a congenital bleeding disorder clinical trial.
Completed
Male
12 Years +
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.
Details for the study
Brief Title
Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
Official Title
Efficacy and Safety of NNC 0129-0000-1003 During Surgical Procedures in Patients With Haemophilia A
Brief Summary
This trial is conducted globally. The aim of this trial is to evaluate the haemostatic effect<br /> of NNC 0129-0000-1003 during surgical procedures in subjects with haemophilia A.
Treatments and/or Procedures
Turoctocog alfa pegol
Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
Outcome Measures
Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.
Primary
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
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
Length of Stay in the Hospital
Mean number of days stayed at the hospital during the trial.
Secondary
Haemostatic Effect of N8-GP 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.
Secondary
Average Consumption of N8-GP During Surgery
Average consumption of N8-GP, during surgery is presented. The time during surgery is defined from 'knife to skin' until 'last stitch'.
Secondary
Haemostatic Effect of N8-GP 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.
Secondary
Average Consumption of N8-GP 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.
Secondary
Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL)
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.
Secondary
Serious Adverse Events Reported During the Trial Period
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).
Secondary
Number of Days in Intensive Care
Mean number of days in the intensive care due to surgery during the trial is presented.
Secondary
Adverse Events Reported During the Trial Period
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).
Secondary
Estimated Blood Loss During Surgery
The mean estimated blood loss following surgery is presented. Estimated blood loss (mL) was evaluated post surgery.
Secondary
Number of Transfusions During the 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.
Study 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