Comparison of the Action of Drugs in the Body and Safety of N8 and Advate® in Haemophilia A Subjects
Phase 1
Completed
- Conditions
- Haemophilia ACongenital Bleeding Disorder
- Interventions
- Registration Number
- NCT00837356
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 23
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
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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®
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Advate®/turoctocog alfa turoctocog alfa - Advate®/turoctocog alfa Advate® -
- Primary Outcome Measures
Name Time Method Recovery of FVIII 30 min after administration, half-life, AUC, and clearance at 30 days
- Secondary Outcome Measures
Name Time Method Inhibitor development at 30 days
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇭Zürich, Switzerland