E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Detection of venous thromboembolism |
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MedDRA Classification |
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 |
To quantitatively determine the imaging properties of EP-2104R for the characterisation of thrombus at different time points post-injection (e.g. signal intensity/enhancement, contrast to noise ratio, assessment of thrombus size). |
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E.2.2 | Secondary objectives of the trial |
- To determine the region-specific sensitivity compared to a reference standard generated by the institution's index diagnostic imaging data. - To qualitatively and quantitatively determine the imaging properties of EP-2104R for vascular imaging post-injection. - To determine the preliminary safety of EP-2104R.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
- able to understand and provide written informed consent - ≥ 18 years of age - have a diagnosis of thrombus by one of the following imaging studies: Cohort A (PE): • CT of the chest • V/Q scan • Pulmonary angiography (XRA, CTA, MRA) Cohort B (DVT): • CT angiography • Ultrasound • Venography If appropriate, another diagnostic imaging exam not listed above may be considered upon doscussion with the sponsor - clinically stable for at least 24 hours prior to first MR imaging session - are a candidate for MR imaging within 48 hours of the index imaging exam - able to undergo an MR scan for at least 30 minutes in the supine position - have a negative pregnancy test at baseline - be clinically stable and in the opinion of the Investigator, have no other lifethreatening illness or organ system dysfunction, which would either intervene with the patient’s safety or interfere with the evaluation of EP-2104R
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E.4 | Principal exclusion criteria |
- Women who are pregnant or lactating - Any major therapeutic intervention (i.e. lysing agent, thrombectomy) between the initial positive imaging study and EP-2104R administration - Specific magnetic resonance exclusion criteria including but not limited to contraindications such as a pacemaker, ear implants, internal defibrillator, internal infusion pumps, ferromagnetic intracranial aneurysm clips, any site-specific MR exclusion, or severe claustrophobia - Patients who are on mechanical ventilation, or are otherwise not considered clinically stable - Patients with receipt of any investigational drug or device within 30 days prior to EP-2104R administration - Patients with a known hypersensitivity to any contrast agent
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E.5 End points |
E.5.1 | Primary end point(s) |
- The signal intensity of the thrombus region as a function of time relative to drug injection - The signal intensity of the blood as a function of time relative to drug injection - The signal intensity of background tissue proximal to the thrombus region as a function of time relative to drug injection - The mean and standard deviation of signal intensity of a uniform region of lung or air outside the body as a function of time relative to drug injection, as an estimate of the noise level |
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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 | No |
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) | 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 | No |
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.8.3 |
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.8.5 | 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Patients will be followed for adverse events for 30 days after receiving last dose of study drug. |
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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 | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |