Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds

Completed · Phase 2

Conditions studied: Congenital Bleeding Disorder, Haemophilia A, Haemophilia B

In brief

This trial is conducted in Africa, Asia, Europe, Japan, and North and South America. The aim of this trial is to evaluate the safety and efficacy of activated recombinant human factor VII analogue (vatreptocog alfa (activated)) in haemophilia patients with inhibitors.

Key facts

Study ID

NCT00486278

Run by

Novo Nordisk A/S

People needed

51

Starts

2007-06-01

Expected to finish

2010-06-01

Last updated by the study team

2017-03-07

Who can join

Age: 12 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 12 years of age or older (at least 18 years in Croatia, France and United Kingdom (UK))
• Clinical diagnosis of congenital haemophilia A or B with a current positive inhibitor titre and a known peak inhibitor of above 5 Bethesda units (BU) (present or in the past) to human FVIII or IX and known antihuman FVIII or IX anamnestic response
• Minimum of 2 joint bleeds (haemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 6 months, or at least 4 joint bleeds (hemarthroses of ankles, knees, or elbows) requiring haemostatic drug treatment within the previous 12 months at trial entry

You may not qualify if…

• Known allergy to rFVIIa, and/or suspected allergy to trial product
• Platelet count lower than 50,000 mm\^3 based on medical records at trial entry (visit 1)
• Any clinical signs or history of thromboembolic events
• Advanced atherosclerotic disease
• Severe liver disease based on medical records within the past 12 months at trial entry (Visit 1), as defined by alanine aminotransferase (ALAT) above 3 times the upper limit of normal reference range
• Known active pseudo tumours (documented bleeding requiring treatment within the last 3 months
• Subject had any (major) surgical procedure in the 30 days prior to screening into the trial. a. Catheter, ports and dental extractions do not count as surgeries and will not exclude the subject

Where it is running

• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Augusta, Georgia, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Indianapolis, Indiana, United States
• Novo Nordisk Investigational Site — Iowa City, Iowa, United States
• Novo Nordisk Investigational Site — Boston, Massachusetts, United States
• Novo Nordisk Investigational Site — Ann Arbor, Michigan, United States
• Novo Nordisk Investigational Site — Minneapolis, Minnesota, United States
• Novo Nordisk Investigational Site — New York, New York, United States
• Novo Nordisk Investigational Site — Chapel Hill, North Carolina, United States
• Novo Nordisk Investigational Site — Cincinnati, Ohio, United States
• Novo Nordisk Investigational Site — Portland, Oregon, United States
• Novo Nordisk Investigational Site — Ciudad Autónoma de Bs. As., Argentina
• Novo Nordisk Investigational Site — Rio de Janeiro, Rio de Janeiro, Brazil
• Novo Nordisk Investigational Site — Campinas, São Paulo, Brazil
• Novo Nordisk Investigational Site — São Paulo, Brazil
• Novo Nordisk Investigational Site — Edmonton, Alberta, Canada
• Novo Nordisk Investigational Site — Zagreb, Croatia
• Novo Nordisk Investigational Site — Lyon, France
• Novo Nordisk Investigational Site — Budapest, Hungary
• Novo Nordisk Investigational Site — Debrecen, Hungary
• Novo Nordisk Investigational Site — Tel Litwinsky, Israel
• Novo Nordisk Investigational Site — Castelfranco Veneto, Italy
• Novo Nordisk Investigational Site — Florence, Italy
• Novo Nordisk Investigational Site — Milan, Italy

Full record on ClinicalTrials.gov

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