E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Central venous access device occlusion |
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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 evaluate the efficacy of alfimeprase compared with placebo as measured by the proportion of subjects with re-establishment of a functional central venous access device 15 minutes following the initial instillation of study drug. |
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E.2.2 | Secondary objectives of the trial |
Evaluate the efficacy of alfimeprase compared with placebo: - The proportion of subjects with re-establishment of a functional central venous access device 30 minutes following the initial instillation of study drug. - The cumulative proportion of subjects with re-establishment of a functional central venous access device 30 minutes following the instillation of one or two doses of study drug Evaluate the safety of alfimeprase compared with placebo: - Adverse event rate during the study period (time from initial instillation of study drug until 120 minutes following the final instillation of study drug) - Serious adverse event rate during the study period (time from initial instillation of study drug until 120 minutes following the final instillation of study drug) - Major bleeding event rate during the study period (time from initial instillation of study drug until 120 minutes following the final instillation of study drug)
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Subjects who meet all of the following criteria will be eligible for enrollment: a) The subject (or legally acceptable representative) must give written informed consent b) Unable to withdraw 3 mL of blood from a central venous access device c) Hemodynamically stable d) Available for follow-up assessments
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E.4 | Principal exclusion criteria |
Subjects who meet any of the following criteria are not eligible for enrollment: a) Inability to infuse at least 2 mL of saline through the catheter b) Catheter placed < 48 hours prior to detection of occlusion c) Catheter used for hemodialysis or pheresis d) < 18 years of age e) Evidence of mechanical or nonthrombotic occlusion f) Receipt of any thrombolytic agent within 24 hours of randomization g) In the opinion of the investigator, subject is at “high risk” for bleeding events or embolic complications, or has a condition for which bleeding constitutes a significant hazard h) Increased risk for drug extravasation i) Pregnant, lactating, or actively menstruating women and women of child-bearing potential who are not using adequate contraceptive precautions (e.g. intrauterine device, oral contraceptives, barrier methods, or other contraception deemed adequate by the investigator). j) Known right-to-left cardiac shunt, patent foramen ovale, or atrial/ventricular septal defect k) Participation in any other study of an investigational device, medication, biologic, or other agent within the 30 days before enrollment and until the 30-day follow up visit l) Any other subject feature that in the opinion of the investigator should preclude study participation
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the proportion of subjects with re-establishment of a functional central venous access device 15 minutes following the initial instillation of study drug. The proportion of catheters with restored function following instillations of study drug will be compared between the treatment groups using a χ2 test. |
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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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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 | Yes |
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 | Yes |
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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The end of the trial is classified as the last patient last visit. |
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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 | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |