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

NCT01238367 — Phase 1, Completed, 6 participants, Novo Nordisk A/S

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT01238367
Status	Completed
Phase	Phase 1
Study type	Interventional; non randomized, single group, masking: none, treatment
Enrollment	6 (Actual)
Sponsor	Novo Nordisk A/S (Industry)
Conditions	Congenital Bleeding Disorder, Haemophilia A
Interventions	turoctocog alfa (Drug)
Dates	start 2010-11-01, primary completion 2011-10-01, completion 2011-10-01, first posted 2010-11-10, last updated 2017-02-10
Locations	6 sites in Japan

-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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
recombinant factor VIII (N8)	Experimental	Drug: turoctocog alfa

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

+Outcome measures

Primary outcomes

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 outcomes

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

+Eligibility

Sex: Male, ages: 12 Years to 66 Years

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

+Locations (6)

Facility	City	Country
Novo Nordisk Investigational Site	Itabashi-ku, Tokyo	Japan
Novo Nordisk Investigational Site	Kashihara-shi, Nara	Japan
Novo Nordisk Investigational Site	Maebashi-shi, Gunma	Japan
Novo Nordisk Investigational Site	Shinjuku-ku, Tokyo	Japan
Novo Nordisk Investigational Site	Shizuoka-shi, Shizuoka	Japan
Novo Nordisk Investigational Site	Suginami-ku, Tokyo	Japan

+Publications

Results publication: Jimenez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Moss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight(R)), in patients with hemophilia A. J Thromb Haemost. 2015 Mar;13(3):370-9. doi: 10.1111/jth.12816. Epub 2015 Feb 13. PMID 25495795

+Investigators

Global Clinical Registry (GCR, 1452), Study director, Novo Nordisk A/S