Phase 3
Completed N=36
Evaluating the Haemostatic Effect of NNC 0129-0000-1003 During Surgical Procedures in Subjects With Haemophilia A.
Congenital Bleeding Disorder · Hemophilia A
Source: ClinicalTrials.gov NCT01489111 ↗
Enrolled (actual)
36
Serious AEs
7.6%
Results posted
Jan 2020
Primary outcomePrimary: 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 — 25; 22; 2; 0 Surgeries
◆ Published Evidence
Emerging
14citations · ~2 / year
Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials.
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.
Linked Publications
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Turoctocog alfa pegol provides effective management for major and minor surgical procedures in patients across all age groups with severe haemophilia A: Full data set from the pathfinder 3 and 5 phase III trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
25; 22; 2; 0 | — |
| SECONDARY Average Consumption of N8-GP During Surgery |
20.7 | — |
| SECONDARY Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6 |
0; 1; 0; 0; 1 | — |
| SECONDARY Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14 |
1; 1; 0; 0 | — |
| SECONDARY Average Consumption of N8-GP During the Post-operative Period Days 1-6 |
33.0 | — |
| SECONDARY Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL) |
— | — |
| SECONDARY Estimated Blood Loss During Surgery |
322.6 | — |
| SECONDARY Number of Transfusions During the Post-operative Period Days 1-6 |
9 | — |
| SECONDARY Length of Stay in the Hospital |
10.00 | — |
| SECONDARY Number of Days in Intensive Care |
0.02 | — |
| SECONDARY Adverse Events Reported During the Trial Period |
127 | — |
| SECONDARY Serious Adverse Events Reported During the Trial Period |
5 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01489111) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.