Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects

Phase 3

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A
• Interventions: Drug: turoctocog alfa

• Registration Number: NCT00840086
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-09
• Study First Posted: 2009-02-10
• Study Start: 2009-04
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Disposition First Submitted: 2012-01-17
• Disposition First Submitted QC: 2012-01-17
• Disposition First Posted: 2012-01-19
• Results First Submitted: 2013-11-14
• Results First Submitted QC: 2014-09-03
• Results First Posted: 2014-09-04
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
rFVIII	turoctocog alfa	-

Primary Outcome Measures

Name	Time	Method
The Incidence Rate of FVIII Inhibitors (Greater Than or Equal to 0.6 Bethesda Units (BU))	The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject.	The incidence rate of FVIII inhibitors was calculated by including all patients with inhibitors in the nominator and including all patients with a minimum 50 exposure plus any patients with less than 50 exposures but with inhibitors in denominator.

Secondary Outcome Measures

Name	Time	Method
Frequency of Adverse Events (AEs)	The adverse events were collected throughout the trial, corresponding to an average of 188 days per subject	Adverse event was defined as events occurring after administration of trial product. Severe AEs: considerable interference with subject's daily activities, unacceptable. Moderate AEs: Marked symptoms, moderate interference with the patient's daily activities. Mild AEs: No or transient symptoms, no interference with the patient's daily activities. Serious AEs: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalization, persistent/significant disability/incapacity/congenital anomaly/birth defect.

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇬🇧 Manchester, United Kingdom