Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A

Congenital Bleeding Disorder Clinical Trial

Official title:

Multi-centre, Open-labelled Trial Investigating the Pharmacokinetics of Four Lots of Turoctocog Alfa in Subjects With Haemophilia A

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01692925
• Other study ID #: NN7008-4015
• Secondary ID: 2012-001444-21U1
• Status: Completed
• Phase: Phase 1
• First received: September 21, 2012
• Last updated: February 9, 2017
• Start date: December 2012
• Est. completion date: March 2013

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 Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial

• Male subjects with the diagnosis of severe haemophilia A (FVIII<1%) from age 18 years

• Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)

• Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count >200/microL)

Exclusion Criteria:

• Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))

• History of FVIII inhibitors

• Severe current hepatic dysfunction or severe hepatic disease during the last 12 months

• Known or suspected allergy to trial product (FVIII) or related products

• Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens

• Body mass index (BMI) above 30 kg/m^2

Related Conditions & MeSH terms

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

Intervention

Drug:
• turoctocog alfa
Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
• turoctocog alfa
Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Frankfurt/M.
Latvia	Novo Nordisk Investigational Site	Riga
Malaysia	Novo Nordisk Investigational Site	Kuala Lumpur
Spain	Novo Nordisk Investigational Site	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Germany,  Latvia,  Malaysia,  Spain, 

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	Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay		up to 48 hours after i.v. administration
Secondary	Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay		up to 48 hours after i.v. administration
Secondary	Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg])		up to 48 hours after i.v. administration
Secondary	Area under the FVIII activity-time curve (AUC)		up to 48 hours after i.v. administration
Secondary	Terminal half-life of FVIII (t½)		up to 48 hours after i.v. administration
Secondary	Clearance of FVIII (CL)		up to 48 hours after i.v. administration
Secondary	Incidence of adverse events (AEs) including FVIII inhibitors		After approximately 3 months (at end of trial)

External Links

•   Clinical Trials at Novo Nordisk