E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with aneurysmal subarachnoid hemorrhage |
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E.1.1.1 | Medical condition in easily understood language |
patients with cerebral bleeding due to an aneurysm |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10007936 |
E.1.2 | Term | Central nervous system aneurysms |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10022758 |
E.1.2 | Term | Intracranial aneurysm |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
evaluating safety in patients with aneurysmal subarachnoid hemorrhage.
and evaluationg the efficacy in preventing delayed cerebral ischemia.
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E.2.2 | Secondary objectives of the trial |
the occurrence of new cerebral infarcts found on CT scan or MR scan 2 weeks after start treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
18-85 years old inclusive,
Subarachnoid hemorrhage diagnosed by CT on admission,
No history of possible traumatic origin of subarachnoid hemorrhage,
Randomizable within 72 hours of subarachnoid hemorrhage,
Saccular intracranial aneurysm proven by cerebral angiography or CTA,
Surgical or endovascular obliteration is successfully performed,
Able to obtain written informed consent from patient or surrogate.
Patients in good clinical grade (WFNS 1-3) (GCS 13-15) at time of randomization.
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E.4 | Principal exclusion criteria |
Pregnancy, as confirmed by routine urine test on admission,
Abnormal renal function at time of randomization (GFR <60 mL/min)
Elevated liver function test at time of randomization (AST > 45 U/L and ALT > 35 U/L.)
History of liver disease or active liver disease, Active renal disease,
Patients with low ferritine (<1000 ng/mL)
Hypersensitivity to deferoxamine,
Patient taking medication not recommended for concomitant use with deferoxamine as per the product label (e.g. high dose vit. C medication).
Patients not able to complete the study follow-up.
The presence of 4 or more of the following risk modifiers for ARDS prior to enrollment:tachypnea (respiratory rate>30), SpO2<95%, Obesity (BMI>30) Acidosis (pH<7.35), Hypoalbuminemia (albumin<3.5g/dL), Concurrent use of chemotherapy
-Tachypnea (respiratory rate >30),
-SpO2 <95%,
-Obesity (BMI >30)
-Acidosis (pH <7.35),
-Hypoalbuminemia (albumin <3.5 g/dL),
-Concurrent use of chemotherapy
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E.5 End points |
E.5.1 | Primary end point(s) |
the occurrence of IMP related adverse events
Number of patients with abnormal renal function
Number of patients with abnormal hepatic function
Number of patients with discontinued medication
number of patients with ARDS
Anaphylaxis at any time point during DFO infusion
the occurrence of DCI |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
14 days after start study, and 6 months |
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E.5.2 | Secondary end point(s) |
number of patients with of delayed cerebral ischemia
number of patients with new cerebral infarction at 2 weeks and at 6 months
mRS after 6 months
extended Glasgow Outcome Scale
EQ-5D quality of life score after 6 months.
any AE prolonging hospital stay, resulting in emergent medical therapy, or resulting in death, regardless of relationship to DFO. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | No |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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number of adverse events related to the IMP is judged above acceptable by DSMB |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |