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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_3

Timeline

Completed

Started Aug 2012

Longer than P75 for phase_3

Geographic Reach

21 countries

70 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.4 years study duration

First Submitted

Initial submission to the registry

November 23, 2011

Completed

16 days until next milestone

First Posted

Study publicly available on registry

December 9, 2011

Completed

8 months until next milestone

Study Start

First participant enrolled

August 3, 2012

Completed

6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2018

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

January 21, 2020

Completed

Last Updated

August 10, 2020

Status Verified

July 1, 2020

Enrollment Period

6.4 years

First QC Date

November 23, 2011

Results QC Date

December 2, 2019

Last Update Submit

July 27, 2020

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

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
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.
Assessed by the Investigator/surgeon at the day of surgery

Secondary Outcomes (11)

Average Consumption of N8-GP During Surgery
During surgery, defined as the time from "knife to skin" until "last stitch"
Haemostatic Effect of N8-GP During the Post-operative Period Days 1-6
During the post-operative period, days 1-6
Haemostatic Effect of N8-GP During the Post-operative Period Days 7-14
During the post-operative period, days 7-14
Average Consumption of N8-GP During the Post-operative Period Days 1-6
During the post-operative period, days 1-6
Incidence Rate of Inhibitors Against Factor VIII (FVIII) (≥0.6 BU/mL)
during the trial (2-5 weeks)
+6 more secondary outcomes

Study Arms (1)

Surgery

EXPERIMENTAL

Drug: turoctocog alfa pegol

Interventions

turoctocog alfa pegolDRUG

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

Also known as: NNC 0129-0000-1003

Surgery

Eligibility Criteria

Age12 Years+

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
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

Contact the study team to confirm eligibility.