Phase 3
N=71
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
Congenital Bleeding Disorder · Haemophilia B
Bottom Line
View on ClinicalTrials.gov: NCT01395810 ↗Enrolled (actual)
71
Serious AEs
7.5%
Results posted
May 2018
Primary outcome: Primary: Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units) — 0; 0; 0; 0 Patients with inhibitory antibodies
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
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Inhibitory Antibodies Against FIX Defined as Titre Above or Equal to 0.6 BU (Bethesda Units) |
0; 0; 0; 0 | — |
| SECONDARY Haemostatic Effect of Nonacog Beta Pegol When Used for Treatment of Bleeding Episodes, Assessed as Success/Failure Based on a Four-point Scale for Haemostatic Response (Excellent, Good, Moderate, Poor) |
97.1; 94.8; 100; 93.2; 94.6; 2.9 | — |
| SECONDARY Number of Bleeding Episodes During Routine Prophylaxis |
1.36; 1.00; 0 | — |
| SECONDARY FIX Trough Levels |
0.098; 0.213 | — |
| SECONDARY Incidence of Adverse Events (AEs) |
2.4; 1.9; 0; 3.2 | — |
| SECONDARY Incidence of Serious Adverse Events (SAEs) |
0.1; 0.1; 0; 0 | — |
Summary
This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term exposure in patients with haemophilia B.
This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773 (NCT01386528/paradigm™ 3).
Eligibility Criteria
Inclusion Criteria
- Previous participation in NN7999-3747 (NCT01333111) and/or NN7999-3773
Exclusion Criteria
- Known history of FIX inhibitors based on existing medical records, laboratory report reviews and patient and LAR (legal acceptable representative) interviews
- Current FIX inhibitors above or equal to 0.6 BU (Bethesda Units)
- 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 (trial physician) judgement, could imply a potential hazard to the patient, interfere with trial participation, or interfere with trial outcome
Data sourced from ClinicalTrials.gov (NCT01395810). 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.