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

Primary Purpose

Congenital Bleeding Disorder, Haemophilia A

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

turoctocog alfa

About this trial

This is an interventional treatment trial for Congenital Bleeding Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Novo Nordisk Investigational Site
Novo Nordisk Investigational Site
Novo Nordisk Investigational Site
Novo Nordisk Investigational Site
Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Lot A

Lot B

Lot C

Lot D

Arm Description

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Outcomes

Primary Outcome Measures

Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay

Secondary Outcome Measures

Dose normalised area under the FVIII activity-time curve (AUC/actual dose) based on one stage clot assay

Incremental recovery (IR30min) (defined as the peak FVIII level recorded 30 min after injection and reported as[IU/mL]/[IU/kg])

Area under the FVIII activity-time curve (AUC)

Terminal half-life of FVIII (t½)

Clearance of FVIII (CL)

Incidence of adverse events (AEs) including FVIII inhibitors

Full Information

NCT ID

NCT01692925

First Posted

September 21, 2012

Last Updated

February 9, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01692925

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

December 2012 (undefined)

Primary Completion Date

March 2013 (Actual)

Study Completion Date

March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Congenital Bleeding Disorder, Haemophilia A

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lot A

Arm Type

Experimental

Arm Description

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Arm Title

Lot B

Arm Type

Experimental

Arm Description

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Arm Title

Lot C

Arm Type

Experimental

Arm Description

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Arm Title

Lot D

Arm Type

Experimental

Arm Description

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Intervention Type

Drug

Intervention Name(s)

turoctocog alfa

Intervention Description

Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Intervention Type

Drug

Intervention Name(s)

turoctocog alfa

Intervention Description

Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.

Primary Outcome Measure Information:

Title

Dose normalised area under the curve (AUC/actual dose) based on chromogenic assay

Time Frame