Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects

A Multi-centre, Multi-national Open-label Sequential Trial Comparing Pharmacokinetics and Safety of N8 and Advate® in Subjects With Haemophilia A

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00837356

Enrollment

Registered

2009-02-05

Start date

2009-03-31

Completion date

2009-10-31

Last updated

2017-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital Bleeding Disorder, Haemophilia A

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.

Interventions

DRUGAdvate®

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

DRUGturoctocog alfa

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

12 Years to 55 Years

Healthy volunteers

Inclusion criteria

* 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

Exclusion criteria

* 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®

Design outcomes

Primary

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

Secondary

Measure	Time frame
Inhibitor development	at 30 days

Countries

Germany, Israel, Italy, Spain, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026