Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects (guardian™1)

Novo Nordisk

Status and phase

Completed

Phase 3

Conditions

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: turoctocog alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT00840086

NN7008-3543

101151 (Registry Identifier)

2008-003960-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

150 patients

Sex

Male

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

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