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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for phase_1

Timeline

Completed

Started Dec 2012

Shorter than P25 for phase_1

Geographic Reach

4 countries

5 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3 months study duration

First Submitted

Initial submission to the registry

September 21, 2012

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed

2 months until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed

3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed

Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

3 months

First QC Date

September 21, 2012

Last Update Submit

February 9, 2017

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (6)

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
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
Area under the FVIII activity-time curve (AUC)
up to 48 hours after i.v. administration
Terminal half-life of FVIII (t½)
up to 48 hours after i.v. administration
Clearance of FVIII (CL)
up to 48 hours after i.v. administration
+1 more secondary outcomes

Study Arms (4)

Lot A

EXPERIMENTAL

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

Drug: turoctocog alfa

Lot B

EXPERIMENTAL

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

Drug: turoctocog alfa

Lot C

EXPERIMENTAL

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

Drug: turoctocog alfa

Lot D

EXPERIMENTAL

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

Drug: turoctocog alfa

Interventions

turoctocog alfaDRUG

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

Lot ALot BLot C

Eligibility Criteria

Age18 Years+

Sexmale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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)

You may not qualify if:

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

Contact the study team to confirm eligibility.