Brief Title
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
Official Title
An Open, Non-Randomised Single and Multiple Dose Trial Investigating the Safety and Pharmacokinetics of Intravenous Administration of Long Acting rFVIIa (LA-rFVIIa) in Patients With Haemophilia A and B
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 recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Frequency of adverse events
Secondary Outcome
Pharmacokinetic parameters based on FVIIa activity. The pharmacokinetic parameters to be reported are: AUC(0-48h), AUC(0-t) and AUC, C10min, Vz, CL, and t½
Condition
Congenital Bleeding Disorder
Intervention
activated recombinant human factor VII, long acting
Study Arms / Comparison Groups
A
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
8
Start Date
June 2009
Completion Date
September 2009
Primary Completion Date
September 2009
Eligibility Criteria
Inclusion Criteria: - Haemophilia A or B - Bodyweight max 100 kg - Body Mass Index (BMI) max 30 kg/m2 - Adequate venous access Exclusion Criteria: - 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
Gender
Male
Ages
18 Years - 55 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT00922792
Organization ID
NN7128-3700
Secondary IDs
2009-010080-16
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
May 2016