Congenital Bleeding Disorder Clinical Trial
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
Verified date | May 2016 |
Source | Novo Nordisk A/S |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 8 |
Est. completion date | September 2009 |
Est. primary completion date | September 2009 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years to 55 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Novo Nordisk A/S |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Frequency of adverse events | after 1 and 2 weeks after dosing | Yes | |
Primary | Frequency of serious adverse events | after 1, 2 and 6-10 weeks after dosing | Yes | |
Primary | Frequency of MESIs (Medical Event of Special Interest) | after 1, 2 and 6-10 weeks after dosing | Yes | |
Primary | Frequency of ocurrence of neutralising antibodies against FVII and/or LA-rFVIIa | after 2 and 6-10 weeks after dosing | Yes | |
Secondary | 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 | from time of dosing up to 72 hours after the last dose | No |
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