A Single Dose Trial of NNC 0155-0000-0004 in Patients With Haemophilia A

Novo Nordisk

Status and phase

Completed

Phase 1

Conditions

Haemophilia A

Congenital Bleeding Disorder

Treatments

Drug: turoctocog alfa

Study type

Interventional

Funder types

Industry

Identifiers

NCT01365520

NN7008-3893

2010-023921-39 (EudraCT Number)

U1111-1118-2228 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Asia and Europe. The aim of the trial is to investigate the pharmacokinetics (the rate at which the trial drug is eliminated from the body) of a single dose of turoctocog alfa (NNC 0155-0000-0004 (N8)) in patients with haemophilia A. Participation in this trial is dependent on previous participation in trial NN7008-3543 (Part B) (NCT00840086).

Enrollment

4 patients

Sex

Male

Ages

12 to 56 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subjects with the diagnosis of severe haemophilia A (factor VIII less than or equal to 1%)
Body weight between 10 to 120 kg
Subjects who have completed NN7008-3543 (Part B) or subjects participating in NN7008-3568 after completion of NN7008-3543 (NCT00840086)

Exclusion criteria

Known or suspected hypersensitivity to trial product(s) or related products
Previous participation in this trial defined as withdrawal
Planned surgery during the trial period (catheter, stents, ports, and dental extractions do not count as surgeries and will not exclude the subject)
Any disease or condition which, according to the trial physician's judgement, could imply a potential hazard to the subject, interfere with the trial participation or trial outcome