Status:
COMPLETED
Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Congenital Bleeding Disorder
Haemophilia A
Eligibility:
MALE
18-55 years
Phase:
PHASE1
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting activated recombina...
Eligibility Criteria
Inclusion
- Haemophilia A or B
- Bodyweight max 100 kg
- Body Mass Index (BMI) max 30 kg/m2
- Adequate venous access
Exclusion
- Known or suspected allergy to trial product(s) or related products (including NovoSeven®)
- The receipt of any investigational product within 30 days prior to enrolment in this trial
- Receipt of Immune Tolerance Induction (ITI) within the last 1 month prior to participation in this trial
- The receipt of any haemostatic treatment for control of a bleeding episode within the last 5 days prior to administration of trial product
- Receipt of FVIII or FIX replacement therapy within 48 hours prior to trial product administration
- Known pseudo tumours
- Congenital or acquired coagulation disorders other than haemophilia A or B
- Any major and/or orthopaedic surgery within one month prior to trial start
- Advanced atherosclerotic disease (defined as known history of ischemic heart disease, ischemic stroke, etc.)
- Clinical signs of renal dysfunction
- Use of platelet inhibitors, including NSAIDs, one week prior to administration of trial drug
- Use of non-prescribed opiate substances
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT00922792
Start Date
June 1 2009
End Date
September 1 2009
Last Update
May 13 2016
Active Locations (1)
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1
Madrid, Spain, 28046