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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: Advate®; Drug: turoctocog alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT00837356

NN7008-3522

2008-002157-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 23 patients

Sex: Male

Ages: 12 to 55 years old

Volunteers: No 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®

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

Advate®/turoctocog alfa

Experimental group

Treatment:

Drug: turoctocog alfa

Drug: Advate®