Safety and Efficacy of NNC-0156-0000-0009 after Long-Term Exposure in Patients with Haemophilia B
- Conditions
- Haemophilia BMedDRA version: 16.0Level: LLTClassification code 10018939Term: Haemophilia B (Factor IX)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2010-023072-17-DE
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 100
Previous participation in NN7999-3747, NN7999-3773
Are the trial subjects under 18? yes
Number of subjects for this age range: 20
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5
• 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 BU;Timepoint(s) of evaluation of this end point: The efficacy endpoints will be evaluated based on all available information until the EOT visit. The safety endpoints will be evaluated based on all available information until the last visit.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): • Haemostatic effect of NNC-0156-0000-0009 when used for treatment of bleeding episodes, assessed on a four-point scale for haemostatic response (excellent, good, moderate and poor) by counting excellent and good as success and moderate and poor as failure<br>• Number of bleeding episodes during routine prophylaxis<br>• FIX trough levels<br>• Adverse Events (AEs) and Serious Adverse Events (SAEs)<br>• General safety endpoints including laboratory parameters, physical examination and vital signs;Timepoint(s) of evaluation of this end point: The efficacy endpoints will be evaluated based on all available information until the EOT visit. The safety endpoints will be evaluated based on all available information until the last visit.