Phase 3
N=13
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
Congenital Bleeding Disorder · Haemophilia B
Bottom Line
View on ClinicalTrials.gov: NCT01386528 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor) — 10; 3; 0; 0 Haemostatic responses
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- nonacog beta pegol (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- Male
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Dec 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor) |
10; 3; 0; 0 | — |
| SECONDARY Consumption of NNC-0156-0000-0009 (U/kg Body Weight) |
328.2 | — |
| SECONDARY Transfusion Requirements (Fulfilling Transfusion Criteria) |
275; 266.7 | — |
| SECONDARY Haemoglobin Pre- and Post-surgery Start |
8.98; 8.37; 7.99 | — |
| SECONDARY Incidence of Adverse Events (AEs) |
12.12 | — |
| SECONDARY Incidence of Serious Adverse Events (SAE) |
— | — |
| SECONDARY Incidence of Inhibitors Against FIX (Coagulation Factor Nine) |
— | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT01386528). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.