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

Congenital Bleeding Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01238367
• Other study ID #: NN7008-3600
• Secondary ID: U1111-1117-1286J
• Status: Completed
• Phase: Phase 1
• First received: November 9, 2010
• Last updated: February 9, 2017
• Start date: November 2010
• Est. completion date: October 2011

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 66 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Coagulation Disorders
• Congenital Bleeding Disorder
• Haemophilia A
• Hemophilia A
• Hemostatic Disorders

Intervention

Drug:
• turoctocog 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.

Locations

Country	Name	City	State
Japan	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

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Japan, 

References & Publications (1)

Jiménez-Yuste V, Lejniece S, Klamroth R, Suzuki T, Santagostino E, Karim FA, Saugstrup T, Møss J. The pharmacokinetics of a B-domain truncated recombinant factor VIII, turoctocog alfa (NovoEight®), in patients with hemophilia A. J Thromb Haemost. 2015 Mar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under the curve		Infusion, 30 minutes
Primary	Incremental recovery		Infusion, 30 minutes
Primary	In vivo t1/2		Infusion, 30 minutes
Primary	Total clearance (CL)		Infusion, 30 minutes
Secondary	Maximal concentration		at 15 minutes
Secondary	Area under the curve		from time zero to last
Secondary	Number of adverse events		from day -1 to day 3 (end of trial)

External Links

•   Clinical Trials at Novo Nordisk