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

Phase 3
Completed
Conditions
blood clotting disorder
Haemophilia B
10064477
Registration Number
NL-OMON39320
Lead Sponsor
ovo Nordisk
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
3
Inclusion Criteria

Previous participation in Paradigm2 or Paradigm3

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
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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