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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
Health authority
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

Study Design


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)
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