E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Central venous access device withdrawl occlusion |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051149 |
E.1.2 | Term | Catheter occlusion |
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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 |
To evaluate the safety profile of alfimeprase as assessed by monitoring of adverse events, serious adverse events and major bleeding events for up to 120 minutes following the instillation of alfimeprase. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of alfimeprase measured by:
The proportion of subjects with re-establishment of a functional CVAD 15 minutes following the instillation of study drug.
The proportion of subjects with re-establishment of a functional CVAD 30 minutes following the instillation of study drug.
The proportion of subjects with re-establishment of a functional CVAD 60 minutes following the instillation of study drug. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects who meet all of the following criteria will be elligible for enrollment:
a) The subject (or legally authorized representative) must give written informed consent. b) Unable to withdraw 3 mL of blood from a central venous access device. c) Hemodynamically stable (i.e. no need for intravenous fluids and/or pressors to maintain blood pressure and/or urine output). 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) Plasminogen activator (e.g. Cathflo Activase) used to treat the current episode of catheter occlusion. e) <18 years of age. f) Any evidence of mechanical or nonthrombic occlusion (prior to subject enrollment, the withdrawl occlusion should be confirmed after repositioning of the subject and asking the subject to move his/her extremities, cough and perform the Valsalva maneuver to minimize the chance that the occlusion is due to mechanical or nonthrombic causes. The investigator may also consider X-ray to radiographically visualise the occluded catheter to rule out obvious mechanical occlusion). g) In the opinion of the investigator, the 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 atriallventricular 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) |
Primary Endpoint: The rates of adverse events, serious adverse events and major bleeding events during the time from instillation of the study drug until up to 120 minutes following the instillation of study drug.
Secondary Endpoints: The proportion of subjects with re-establishment of a functional central venous access device 15 minutes following the instillation of study drug.
The proportion of subjects with re-establishment of a functional central venous access device 30 minutes following the instillation of study drug.
The proportion of subjects with re-establishment of a functional central venous access device 60 minutes following the instillation of study drug. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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.8.3 |
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 | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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 | 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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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 |