Phase 3 N=65 Treatment

Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A

Congenital Bleeding Disorder · Haemophilia A

Bottom Line

View on ClinicalTrials.gov: NCT01138501 ↗

Enrolled (actual)

Serious AEs

4.8%

Results posted

Jun 2014

Primary outcome: Primary: The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU)) — 0 N with Inhibitors / N with ≥50 EDs

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: turoctocog alfa (Drug)
Age: Pediatric
Sex: Male
Sponsor: Novo Nordisk A/S
Primary completion: Nov 2011

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	—

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.

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)

View full record on ClinicalTrials.gov →

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.