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

Phase 1

Completed

• Conditions: Congenital Bleeding Disorder; Haemophilia A
• Interventions: Drug: turoctocog alfa

• Registration Number: NCT01692925
• Lead Sponsor: Novo Nordisk A/S

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-21
• Study First Posted: 2012-09-26
• Study Start: 2012-12
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lot A	turoctocog alfa	Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Lot B	turoctocog alfa	Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Lot C	turoctocog alfa	Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.
Lot D	turoctocog alfa	Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Primary Outcome Measures

Name	Time	Method
Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay	up to 48 hours after i.v. administration

Secondary Outcome Measures

Name	Time	Method
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
Clearance of FVIII (CL)	up to 48 hours after i.v. administration
Incidence of adverse events (AEs) including FVIII inhibitors	After approximately 3 months (at end of trial)
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
Terminal half-life of FVIII (t½)	up to 48 hours after i.v. administration
Area under the FVIII activity-time curve (AUC)	up to 48 hours after i.v. administration

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇪🇸 Madrid, Spain