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

Congenital Bleeding Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01365520
• Other study ID #: NN7008-3893
• Secondary ID: 2010-023921-39U1
• Status: Completed
• Phase: Phase 1
• First received: May 30, 2011
• Last updated: February 9, 2017
• Start date: June 2011
• Est. completion date: September 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 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 12 Years to 56 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• turoctocog 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.

Locations

Country	Name	City	State
Malaysia	Novo Nordisk Investigational Site	Kuala Lumpur
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	London

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Malaysia,  United Kingdom, 

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, 48 hours
Primary	Incremental recovery		Infusion, 30 minutes
Primary	In vivo t1/2		Infusion, 48 hours
Primary	Total clearance (CL)		Infusion, 48 hours
Secondary	Maximal concentration (Cmax)		15 minutes after trial drug administration
Secondary	Number of adverse events		up to 48 hours after trial drug administration

External Links

•   Clinical Trials at Novo Nordisk