12 and older, male only, with Congenital Bleeding Disorder or Haemophilia A. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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 NonePrimary· 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.
Excellent
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
25
Good
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
22
Moderate
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
2
None
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
0
Average Consumption of N8-GP During SurgerySecondary· 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'.
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
20.7
± 0.0
Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6Secondary· 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.
Excellent
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
0
Good
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
1
Moderate
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
0
None
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
0
Missing
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
1
Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14Secondary· 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.
Excellent
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
1
Good
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
1
Moderate
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
0
None
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
0
Average Consumption of N8-GP During the Post-operative Period Days 1-6Secondary· 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.
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
33.0
± 10.2
Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL)Secondary· 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.
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
0
Estimated Blood Loss During SurgerySecondary· During surgery
The mean estimated blood loss following surgery is presented. Estimated blood loss (mL) was evaluated post surgery.
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
322.6
± 745.0
Number of Transfusions During the Post-operative Period Days 1-6Secondary· 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.
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
9
Length of Stay in the HospitalSecondary· During the trial (2-5 weeks)
Mean number of days stayed at the hospital during the trial.
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
10.00
± 8.9
Number of Days in Intensive CareSecondary· During the trial (2-5 weeks)
Mean number of days in the intensive care due to surgery during the trial is presented.
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
0.02
± 0.14
Adverse Events Reported During the Trial PeriodSecondary· 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).
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
127
Serious Adverse Events Reported During the Trial PeriodSecondary· 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).
Group
Value
95% CI
NNC 0129-0000-1003 (Turoctocog Alfa Pegol)
5
Adverse events — posted to ClinicalTrials.gov
Time frame: From the first trial related activity (day 0) after the patient has signed the informed consent until the end of trial (earliest at day 14)..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02994407 — Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemo
· Phase 1
· completed
NCT02920398 — A Multi-centre, Comparative, Double Blind, Randomised Cross-over Trial Investigating Single Dose Pharmacokinetics and Sa
· Phase 1
· completed
NCT02137850 — Safety and Efficacy of Turoctocog Alfa Pegol (N8-GP) in Previously Untreated Patients With Haemophilia A
· Phase 3
· completed
NCT01731600 — A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Prev
· Phase 3
· completed
NCT01480180 — Evaluation of Safety and Efficacy, Including Pharmacokinetics, of NNC 0129-0000-1003 When Administered for Treatment and
· Phase 3
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novo Nordisk A/S
Last refreshed: 10 August 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01489111.