Brief Summary

This trial is conducted in Europe and Asia. The aim of this clinical trial is to compare two recombinant factor VIII drugs, turoctocog alfa (recombinant factor VIII (N8)) with Advate®, in haemophilia A subjects, investigating the action and safety of the drugs.

Trial Health

On Track

Trial Health Score

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

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Mar 2009

Shorter than P25 for phase_1

Geographic Reach

5 countries

7 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

7 months study duration

First Submitted

Initial submission to the registry

February 4, 2009

Completed

1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed

24 days until next milestone

Study Start

First participant enrolled

March 1, 2009

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed

Last Updated

February 10, 2017

Status Verified

February 1, 2017

Enrollment Period

7 months

First QC Date

February 4, 2009

Last Update Submit

February 9, 2017

Conditions

Congenital Bleeding Disorder Haemophilia A

Outcome Measures

Primary Outcomes (1)

Recovery of FVIII 30 min after administration, half-life, AUC, and clearance
at 30 days

Secondary Outcomes (1)

Inhibitor development
at 30 days

Study Arms (1)

Advate®/turoctocog alfa

EXPERIMENTAL

Drug: Advate®Drug: turoctocog alfa

Interventions

Advate®DRUG

Subjects will receive Advate® at a dose of 50 IU/kg body weight in the first session

Advate®/turoctocog alfa

turoctocog alfaDRUG

After a washout period of 4 days, subjects will subsequently receive turoctocog alfa (recombinant factor VIII (N8)) at a dose of 50 IU/kg body weight in the second session

Also known as: recombinant FVIII, N8

Advate®/turoctocog alfa

Eligibility Criteria

Age12 Years - 55 Years

Sexmale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

Severe haemophilia A (FVIII level less than or equal to 1%)
Treatment history of more than 150 exposure days with recombinant or plasma-derived FVIII replacement products
HIV or HCV negative, or if positive the patient is on a stable antiviral regimen at the time of the enrolment in the trial

You may not qualify if:

Presence of any bleeding disorder in addition to haemophilia A
Inhibitor titre greater than or equal to 0.6 Bethesda Units (BU) at screening and past history of inhibitor
Abnormal renal function tests
Known hypersensitivity to Advate®

Contact the study team to confirm eligibility.