Acute Intracerebral Haemorrhage MedDRA version: 7.1 Level: LLT Classification code 10022753
Conditions
Interventions
Product Name: NovoSeven
Product Code: rFVIIa
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: eptacog alfa (activated)
CAS Number: 102786-61-8
Other descriptive
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Spontaneous ICH (including bleeding in brainstem and cerebellum) diagnosed by CT scan within 3 hours of symptom onset 2. Male or female patients, aged =18 years (=20 in Taiwan) 3. Informed consent obtained before any trial related activities*. If permitted by local legislation informed consent can be provided by next of kin/legally authorized representative (LAR). Consent must also be obtained by the patient as soon as he/she is able to do so *Trial-related activities are any procedure that would not have been performed during normal management of the patient. Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. Time of symptom onset of ICH is unknown or more than 3 hours 2. Patients with secondary ICH related to infarction, tumour, haemorrhagic infarction, cerebrovenous thrombosis, aneurysm, arteriovenous malformations (AVM), thrombolysis or severe trauma 3. Surgical haematoma evacuation planned within 24 hours of symptom onset 4. Deep coma (GCS 3-5) at the time of admission 5. Known oral anti-coagulant use (unless the INR is documented below 1.4); aspirin use is not an exclusion criterion 6. Known thrombocytopenia (unless current platelets documented above 50000/µL) 7. Pre-existing disability (i.e. must have a mRS score of 0-2 before stroke) 8. Any known history of haemophilia or other coagulopathy 9. Known acute myocardial ischemia, unresolved unstable angina, acute septicaemia, acute crush injury, acute disseminated intravascular coagulation (DIC) or acute thrombotic stroke 10. Pregnancy 11. Known or suspected allergy to trial product or related products 12. Previous participation in this trial 13. Known participation in ANY investigational drug or device trial within 30 days of entry into this trial 14. Patients known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to evaluate the efficacy of rFVIIa (NovoSeven®/Niastase®) in reducing disability and improving clinical outcome by preventing early haematoma growth in patients with acute intracerebral haemorrhage (ICH);Secondary Objective: The secondary objective of this trial is to evaluate the safety of rFVIIa (NovoSeven®/Niastase®) in reducing disability and improving clinical outcome by preventing early haematoma growth in patients with acute intracerebral haemorrhage (ICH);Primary end point(s): The primary efficacy endpoint is poor outcome, defined as death or severe disability (scores of 5-6) on the modified Rankin Scale (mRS) at Day 90. Secondary efficacy endpoints are: •mRS at Day 90 only pooling the categories 5 and 6, thus having 6 categories •The absolute and percent change in ICH volume as measured by CT head scans from prior to dosing to 24 hours after trial drug administration •Good outcome on Day 90, defined as mRS 0-1 •The absolute and percent change in total lesion volumes (ICH + IVH + edema) from baseline to the 72 hours CT-scan •The Barthel Index (BI) at Day 90 •Mortality The safety endpoints are: • The occurrence of adverse events until hospital discharge or until Day 90 whichever comes first, and serious adverse events until the End of Trial Form is completed. | — |
Countries
Denmark, Finland, Germany, Italy, Norway, Spain, Sweden, United Kingdom
Outcome results
None listed