Phase 3
Completed N=65
Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A
Congenital Bleeding Disorder · Hemophilia A
Source: ClinicalTrials.gov NCT01138501 ↗
Enrolled (actual)
65
Serious AEs
4.8%
Results posted
Jun 2014
Primary outcomePrimary: The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)) — 0 N with Inhibitors / N with ≥50 EDs
Summary
This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)) |
— | — |
| SECONDARY Frequency of Adverse Events (AEs) |
86; 0; 11; 74; 3; 2 | — |
Eligibility Criteria
Inclusion Criteria
- Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A
- Age below 12 years and weight at least 11 kg
Exclusion Criteria
- Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures)
- Congenital or acquired coagulation disorders other than haemophilia A
- Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)
Data sourced from ClinicalTrials.gov (NCT01138501). 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.