A randomised, open-label, multi-centre trial investigating the intra-subject variability of ROTEM® and TEG® parameters following two intravenous administrations of the same dose of activated recombinant factor VII (rFVIIa/NovoSeven®) in haemophilia patients in a non-bleeding state

• Conditions: Haemophilia; MedDRA version: 7.1Level: LLTClassification code 10061992

• Registration Number: EUCTR2005-000891-42-DK
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-07-08
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the patient.)
• Confirmed diagnosis of congenital haemophilia A or B with a FVIII:C or FIX:C one stage activity, respectively, at less than 5% of normal (based on medical records) +/- inhibitors (a positive inhibitor status defined as >0.6 Bethesda units)
• Male subjects, 16 years of age or more
• Non-bleeding state (i.e. no clinical manifestation of active bleed) at the time of administration of trial product

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years)
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Known or suspected allergy to trial product or any of its components or to related products
• Previous participation in this trial defined as randomisation of the patient
• Known clinically relevant coagulation disorders or insufficiencies other than congenital haemophilia A or B
• Platelet count < 50,000 platelets/µL
• Received any haemostatic treatment (e.g. Feiba) within the last 7 days prior to administration of trial product, except for rFVIIa
• Received rFVIIa within the last 48 hours prior to administration of trial product
• Participation in any other trial involving investigational products within the last 30 days prior to administration of trial product
• Received immunosuppressive-immunomodulatory drugs within the last 30 days prior to administration of trial product
• Advanced atherosclerotic disease, incl. any history of thrombotic disorder (myocardial infarction, deep vein thrombosis, pulmonary embolism, stroke or peripheral arterial thrombosis)
• Septicaemia, e.g. febrile illness within 5 days prior to trial product administration
• Renal insufficiency defined as current dialysis therapy or creatinine levels above normal range (according to local laboratory range)
• Hepatic disease
? Patients with significant hepatic enzyme elevation (ALAT x 2 upper reference limit and/or PT<70%)
? Known current hepatic dysfunction or severe hepatic disease during the last 12 months.
• Any disease or condition which, according to the Investigator´s judgement, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome
• Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified