An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 during Surgical Procedures in Patients with Haemophilia B

Phase 3

Withdrawn

Conditions: blood clotting disorder
Haemophilia B
10064477

Registration Number: NL-OMON36798

Lead Sponsor: ovo Nordisk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 2

Inclusion Criteria

• Male patients, aged 13-70 years, with moderately severe or severe congenital haemophilia B with a FIX activity <=2% according to medical records
NB: In The Netherlands only patients aged 18-70 years will be included
• History of at least 150 exposure days to other FIX products
• Scheduled major surgery

Exclusion Criteria

• Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR interviews
• Current FIX inhibitors >=0.6 BU (central laboratory)
• 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)
• ALT >3 times the upper limit of normal reference ranges at screening (central laboratory)
• Immune modulating or chemotherapeutic medication

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint: Haemostatic effect during surgery evaluated by a four-point<br /><br>response scale (Excellent, good, moderate poor), assessed by the<br /><br>Investigator/Surgeon at the day of surgery</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key Secondary Endpoints:<br /><br>• Consumption of N9-GP (U/kg Body Weight) during surgery and post-operative<br /><br>period<br /><br>• Transfusion requirements during surgery and the post-operative period<br /><br>• Haemoglobin pre and post surgery start (0, 1 h, 24 h and every 24 hours in<br /><br>the post-operative period)<br /><br>• AE and SAEs reported during the trial period until the last visit<br /><br>• Incidence of inhibitors against FIX (>=0.6 BU) until the last visit</p><br>