Efficacy and Safety of NNC 0129-0000-1003 during Surgical Procedures in Patients with Haemophilia A

Phase 3

Completed

Conditions: blood clotting disorder
Haemophilia A
10064477

Registration Number: NL-OMON44118

Lead Sponsor: ovo Nordisk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 1

Inclusion Criteria

- Ongoing participation in the pathfinder2 (NN7088-3859) trial and having received *5 doses of N8-GP
- Undergoing major surgery

Exclusion Criteria

- Known or suspected hypersensitivity to trial product including allergy to hamster protein or related products
- Previous withdrawal from the pathfinder2 (NN7088-3859) trial after administration of trial product, except interruption due to inclusion in this pathfinder3 trial (NN7088-3860)
- The receipt of any investigational medicinal product (except N8-GP) within 30 days prior to enrolment into the trial.
- FVIII inhibitors * 0.6 BU/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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint:<br /><br>* Haemostatic effect during surgery evaluated by the four-point scale<br /><br>(excellent, good, moderate or none), assessed by the Investigator/surgeon at<br /><br>the day of surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary Endpoints:<br /><br>* Average consumption of N8-GP during surgery<br /><br>* Haemostatic effect of N8-GP during the post-operative period Days 1-6 and 7-14<br /><br>* Average consumption of N8-GP during the post-operative period Days 1-6<br /><br>* Incidence rate of inhibitors against factor VIII (FVIII) (*0.6 BU/mL)</p><br>