Phase 3
N=150
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
Congenital Bleeding Disorder · Haemophilia A
Bottom Line
View on ClinicalTrials.gov: NCT00840086 ↗Enrolled (actual)
150
Serious AEs
4.7%
Results posted
Sep 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, Adult, Older Adult · 12+ yrs
- Sex
- Male
- Sponsor
- Novo Nordisk A/S
- Primary completion
- Sep 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) |
222; 3; 225; 8; 0; 8 | — |
Summary
This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.
Eligibility Criteria
Inclusion Criteria
- Male subjects with the diagnosis of severe (FVIII less than or equal to 1%) haemophilia A from age 12 (except for Israel where the age limit will be 18 for the first 10 subjects recruited in the trial) to 56 years having a weight of 10 to 120 kg
- Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
- No history of FVIII inhibitors greater than or equal to 0.6 BU/mL. The inhibitor should be measured regularly for at least the last 8 years or since the first treatment of haemophilia A
- No detectable inhibitors to FVIII (greater than or equal to 0.6 BU/mL) (as assessed by a Central Laboratory at the time of screening)
Exclusion Criteria
- Congenital or acquired coagulation disorders other than haemophilia A
- Creatinine levels 50% above normal level (as defined by central laboratory range)
- Known or suspected allergy to trial product (N8) or related products
Data sourced from ClinicalTrials.gov (NCT00840086). 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.