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

Multi-Centre, Open-Label, Randomised Trial Investigating the Pharmacokinetics of a Single Dose of NNC 0155-0000-0004 (N8) in Patients With Haemophilia A

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01365520

Enrollment

Registered

2011-06-03

Start date

2011-06-30

Completion date

2011-09-30

Last updated

2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Haemophilia A

Brief summary

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).

Interventions

DRUGturoctocog alfa

A single dose will be administered i.v. (into the vein). Subjects will be randomised to one of two lots of NNC 0155-0000-0004.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

12 Years to 56 Years

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

Design outcomes

Primary

Measure	Time frame
Area under the curve	Infusion, 48 hours
Incremental recovery	Infusion, 30 minutes
In vivo t1/2	Infusion, 48 hours
Total clearance (CL)	Infusion, 48 hours

Secondary

Measure	Time frame
Maximal concentration (Cmax)	15 minutes after trial drug administration
Number of adverse events	up to 48 hours after trial drug administration

Countries

Malaysia, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026