Brief Title
Haemophilia Patients With Inhibitors Being Treated for Acute Joint Bleeds
Official Title
A Multi-centre, Randomised, Double-blinded, Controlled, Dose-escalation Trial on Safety and Efficacy of Activated Recombinant FVII Analogue (NN1731) in the Treatment of Joint Bleeds in Congenital Haemophilia Patients With Inhibitors
Brief Summary
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.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Number of Adverse Events (AEs)
Secondary Outcome
Activated Recombinant Human Factor VII Analogue Activity in the Blood
Condition
Congenital Bleeding Disorder
Intervention
eptacog alfa (activated)
Study Arms / Comparison Groups
vatreptacog alfa 5 mcg/kg
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
51
Start Date
June 2007
Completion Date
June 2010
Primary Completion Date
June 2010
Eligibility Criteria
Inclusion Criteria: - 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 Exclusion Criteria: - 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
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Argentina
Location Countries
Argentina
Administrative Informations
NCT ID
NCT00486278
Organization ID
NN1731-1804
Secondary IDs
2006-004879-35
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
January 2017