A Single Dose Trial of Recombinant Factor VIII (N8) in Japanese Subjects With Haemophilia A: An Extension to Trial NN7008-3543

Multi-centre, Open-label, Non-randomised Single Dose Trial Investigating the Pharmacokinetics of N8 in Japanese Subjects With Haemophilia A

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01238367

Enrollment

Registered

2010-11-10

Start date

2010-11-30

Completion date

2011-10-31

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 Japan. The aim of this clinical trial is to investigate the pharmacokinetics (the effect of the investigated drug on the body) and safety of turoctocog alfa (recombinant factor VIII (N8)) in Japanese subjects with haemophilia A.

Interventions

DRUGturoctocog alfa

Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

12 Years to 66 Years

Healthy volunteers

Inclusion criteria

* Japanese subjects who have completed NN7008-3543 * No detectable inhibitors to factor VIII

Exclusion criteria

* Congenital or acquired coagulation disorders other than haemophilia A * Planned surgery during the trial period * Receipt of any investigational drug other than recombinant factor VIII (N8) within 30 days of trial product administration

Design outcomes

Primary

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

Secondary

Measure	Time frame
Area under the curve	from time zero to last
Number of adverse events	from day -1 to day 3 (end of trial)
Maximal concentration	at 15 minutes

Countries

Japan

Outcome results

None listed

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