Phase 3
N=213
Safety and Efficacy of Turoctocog Alfa (N8) in Prevention and On-demand Treatment of Bleeding Episodes in Subjects With Haemophilia A: An Extension to Trials NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 and NN7008-4015
Congenital Bleeding Disorder · Haemophilia A
Bottom Line
View on ClinicalTrials.gov: NCT00984126 ↗Enrolled (actual)
213
Serious AEs
19.3%
Results posted
Jul 2017
Primary outcome: Primary: Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) — 0; 0; 0; 0 subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- turoctocog alfa (Drug)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- Male
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Jun 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) |
0; 0; 0; 0 | — |
| SECONDARY Frequency of Adverse Events and Serious Adverse Events |
180; 204; 240; 636; 6; 8 | — |
| SECONDARY Annualised Bleeding Rate Reported During the Prevention Period (Only Applicable for Subjects in the Preventive Regimen) |
1.08; 1.57; 1.57; 1.37 | — |
| SECONDARY Haemostatic Response to Turoctocog Alfa (None, Moderate, Good or Excellent) in Treatment of Bleeds. |
124; 189; 72; 565; 1; 150 | — |
Summary
This trial is conducted in Asia, Europe, Japan, Oceania, North America and South America.
The aim of the trial is to investigate the safety and efficacy of turoctocog alfa (N8) in Haemophilia A patients.
The trial is an extension to trials NN7008-3543 (start: March 2009, stop: September 2011) and NN7008-3545 (start: May 2010, stop: November 2011) and the pharmacokinetic trials NN7008-3600 (start: November 2010, stop: October 2011), NN7008-3893 (start: June 2011, stop: September 2011) and NN7008-4015 (start: August 2012, stop: March 2013).
Eligibility Criteria
Inclusion Criteria
- Informed Consent obtained before any trial-related activities
- Completion of trial NN7008-3543 or paediatric trial NN7008-3545 or Japanese trial NN7008-3600 or pharmacokinetic trial NN7008-3893 or NN7008-4015
Exclusion Criteria
- Previous participation in the current trial (defined as withdrawal) or withdrawn subjects from NN7008-3522, NN7008-3543, NN7008-3545, NN7008-3600, NN7008-3893 or NN7008-4015 after administration of trial product
Data sourced from ClinicalTrials.gov (NCT00984126). 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.