An Open-label, Multi-centre, Un-controlled Trial to Assess Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Patients With Haemophilia B
Overview
- Phase
- Phase 3
- Intervention
- nonacog beta pegol
- Conditions
- Congenital Bleeding Disorder
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This trial is conducted in Africa, Asia, Europe and the United States of America (USA).
The aim of the trial is to evaluate the safety and efficacy of NNC-0156-0000-0009 (nonacog beta pegol) during surgical procedures in patients with haemophilia B.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients with haemophilia B with a FIX activity below or equal to 2%
- •Male patients with moderately severe or severe congenital haemophilia B with a FIX activity below or equal to 2% according to medical records
- •History of at least 150 exposure days to other FIX products
- •Scheduled major surgery
Exclusion Criteria
- •Known history of FIX (coagulation factor nine) inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
- •Current FIX (coagulation factor nine) inhibitors above or equal to 0.6 Bethesda Units (central laboratory)
- •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)
- •ALT (alanine aminotransferase) 3 times the upper limit of normal reference ranges at screening (central laboratory)
- •Immune modulating or chemotherapeutic medication
Arms & Interventions
Patients enrolled in trial
New patients will be included as well as transferred patients from Paradigm™ 2 or Paradigm™ 4 trial
Intervention: nonacog beta pegol
Outcomes
Primary Outcomes
Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor)
Time Frame: At the day of surgery
Haemostatic effect during surgery was evaluated immediately after surgery (last stitch) using a fourpoint response scale: - Four-point response scale: Excellent, good, moderate, poor. The evaluation was done by the surgeon, anaesthesiologist and/or investigator based on experience as follows: 1. Excellent: Better than expected/predicted in this type of procedure. 2. Good: As expected in this type of procedure. 3. Moderate: Less than optimal for the type of procedure but haemostatic response maintained without change of treatment regimen. 4. Poor: Bleeding due to inadequate therapeutic response with adequate dosing, change of regimen required.
Secondary Outcomes
- Incidence of Adverse Events (AEs)(during the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13))
- Incidence of Serious Adverse Events (SAE)(During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) until 4 weeks after post-operative period (day 1 to day 13))
- Haemoglobin Pre- and Post-surgery Start(0, 1 hour, 24 hours.)
- Consumption of NNC-0156-0000-0009 (U/kg Body Weight)(During surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13))
- Transfusion Requirements (Fulfilling Transfusion Criteria)(during surgery (the time from knife to skin until last stitch) and post-operative period (day 1 to day 13))
- Incidence of Inhibitors Against FIX (Coagulation Factor Nine)(During the trial period (2-8 weeks prior to day of surgery (transferred subjects) or 2-4 weeks prior to day of surgery (new subjects) and every 4 weeks after post-operative period (day 1 to day 13))