Phase 3
Completed 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 · Hemophilia A
Source: ClinicalTrials.gov NCT00984126 ↗
Enrolled (actual)
213
Serious AEs
19.3%
Results posted
Jul 2017
Primary outcomePrimary: Frequency of Development of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)/mL) — 0; 0; 0; 0 subjects
◆ Published Evidence
Emerging
9citations · ~1 / year
Long-term patterns of safety and efficacy of bleeding prophylaxis with turoctocog alfa (NovoEight(®) ) in previously treated patients with severe haemophilia A: interim results of the guardian(™) 2 extension trial.
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).
Linked Publications (2)
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Long-term patterns of safety and efficacy of bleeding prophylaxis with turoctocog alfa (NovoEight(®) ) in previously treated patients with severe haemophilia A: interim results of the guardian(™) 2 extension trial.
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Interim results from a large multinational extension trial (guardian(™) 2) using turoctocog alfa for prophylaxis and treatment of bleeding in patients with severe haemophilia A.
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 | — |
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) and the linked publication. 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.