Safety and Efficacy of NNC-0156-0000-0009 after Long-Term Exposure in Patients with Haemophilia B - paradigm™4

Conditions: Haemophilia B
MedDRA version: 14.1Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 100000004850

Registration Number: EUCTR2010-023072-17-NL

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: Male

Target Recruitment: 100

Inclusion Criteria

Previous participation in NN7999-3747 or NN7999-3773
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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
• Congenital or acquired coagulation disorders other than haemophilia B
• 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)
• 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 interfere with trial outcome

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the immunogenicity of NNC-0156-0000-0009.;Secondary Objective: • To evaluate clinical efficacy of haemostasis (treatment of bleeding episodes) of<br>NNC-0156-0000-0009<br>• To evaluate clinical efficacy of NNC-0156-0000-0009 in long term bleeding prophylaxis (number of bleeding episodes during prophylaxis)<br>• To evaluate efficacy of NNC-0156-0000-0009 by the surrogate marker for efficacy, FIX activity<br>• To evaluate general safety of NNC-0156-0000-0009;Primary end point(s): Incidence of inhibitory antibodies against FIX defined as titre =0.6 B

Secondary Outcome Measures