Safety and Efficacy of nonacog beta pegol (N9-GP) in Previously Untreated Patients with Haemophilia B

Phase 3

Recruiting

Conditions: Haemophilia B / blood clotting disorder
10064477

Registration Number: NL-OMON50546

Lead Sponsor: ovo Nordisk

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 1

Inclusion Criteria

- Informed consent obtained before any trial-related activities. Trial-related
activities are any procedures that are carried out as part of the trial,
including activities to determine suitability for the trial, - Male, < 6 years
of age at the time of signing informed consent, - Patients with the diagnosis
of haemophilia B (FIX activity level <= 2%) based on medical records or central
laboratory results, - Previously untreated or exposed to FIX containing
products less than or equal to 3 exposure days (5 previous exposure days to
blood components are acceptable)

Exclusion Criteria

- Any history of FIX inhibitors (defined by medical records), - Known or
suspected hypersensitivity to trial product or related products, - Previous
participation in this trial. Participation is defined as first dose
administered of trial product, - Receipt of any investigational medicinal
product within 30 days before screening, - Congenital or acquired coagulation
disorder other than haemophilia B, - Any chronic disorder or severe disease
which, in the opinion of the Investigator, might jeopardise patient*s safety or
compliance with the protocol, - Patient*s parent(s)/LAR(s) mental incapacity,
unwillingness to cooperate, or a language barrier precluding adequate
understanding and cooperation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary Endpoint<br /><br>• Incidence of inhibitory antibodies against FIX </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Key Secondary Endpoint<br /><br>• Number and frequency of adverse events, serious adverse events, and Medical<br /><br>Events of Special Interest<br /><br>• Number of breakthrough bleeding episodes during prophylaxis (annualised<br /><br>bleeding rate)<br /><br>• Haemostatic effect by 4-point haemostatic response scale (excellent,<br /><br>good, moderate and poor)</p><br>