E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Acute Intracerebral Haemorrhage |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 7.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10022753 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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) |
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E.2.2 | Secondary objectives of the trial |
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) |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal 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.
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E.4 | Principal 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. Any other condition which, in the judgement of the Investigator, might increase the risk to the patient or preclude the satisfactory ability to collect experimental data
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is poor outcome, defined as dead 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 baseline scan •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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Information not present in EudraCT |
E.8.4 | The trial involves multiple sites in the Member State concerned | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | Information not present in EudraCT |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Information not present in EudraCT |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 9 |