Status:
COMPLETED
A Research Study Investigating Nonacog Beta Pegol (N9-GP) for Treatment and Prevention of Bleedings in Chinese People With Haemophilia B
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Haemophilia B
Eligibility:
MALE
12-70 years
Phase:
PHASE3
Brief Summary
The study investigates how well the medicine called nonacog beta pegol (N9-GP) works in Chinese people with haemophilia B. Participants will be treated with N9-GP. This is a medicine that doctors can ...
Eligibility Criteria
Inclusion
- 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 Chinese patient with moderate to severe congenital haemophilia B with a factor IX (FIX) activity less than or equal to 2 percent according to medical records.
- Aged 12-70 years (both inclusive) at the time of signing informed consent.
- History of at least 100 exposure days (EDs) to products containing FIX.1.
- Patients currently on prophylaxis or patients currently treated on-demand with at least 6 bleeding episodes during the last 12 months or at least 3 bleeding episodes during the last 6 months.
- The patient, legally authorised representative (LAR) and/or caregiver are capable of assessing a bleeding episode, keeping a diary, performing home treatment of bleeding episodes and otherwise following the trial procedures.
Exclusion
- Known or suspected hypersensitivity to trial product or related products.
- Previous participation in this trial. Participation is defined as signed informed consent.
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 5 half-lives or 30 days from screening, whichever is longer.
- Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR interviews.
- Current FIX inhibitors greater than or equal to 0.6 Bethesda unit (BU).
- HIV positive, defined by medical records, with CD4+ count less than or equal 200 per microlitre (μL) and a viral load greater than 200 particles per microlitre or greater than 400000 copies per millilitre (mL) within 6 months of the trial entry. If the data are not available in the medical records within the last 6 months, then the test must be performed at the screening visit.
- Congenital or acquired coagulation disorder 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).
- Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) greater than 3 times the upper limit of normal combined with total bilirubin greater than 1.5 times the upper limit of normal at screening.
- Renal impairment defined as estimated glomerular filtration rate (eGFR) less than or equal to 30 mL/min/1.73 m\^2 for serum creatinine measured at screening.
- Any disorder, except for conditions associated with haemophilia B, which in the investigator's opinion might jeopardise the patient's safety or compliance with the protocol.
- Platelet count less than 50×10\^9/L at screening.
- Immune modulating or chemotherapeutic medication.
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
Key Trial Info
Start Date :
May 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05365217
Start Date
May 18 2022
End Date
May 11 2024
Last Update
May 31 2025
Active Locations (14)
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1
Beijing Children's Hospital，Capital Medical University
Beijing, Beijing Municipality, China, 100045
2
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100730
3
Fujian Medical University Union Hospital-Hematology
Fuzhou, Fujian, China, 350001
4
Haemotology, Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, China, 510515