Phase 3
Completed N=13
Efficacy and Safety of NNC-0156-0000-0009 During Surgical Procedures in Subjects With Haemophilia B
Congenital Bleeding Disorder · Haemophilia B
Source: ClinicalTrials.gov NCT01386528 ↗
Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcomePrimary: Haemostatic Effect During Surgery Evaluated by the Four-point Response Scale (Excellent, Good, Moderate, Poor) — 10; 3; 0; 0 Haemostatic responses
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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) |
— | — |
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. Informational only — not medical advice.