E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Thrombotic occlusion of central venous access devices |
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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 safety and efficacy of microplasmin in patients with long term venous access catheter thrombosis. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
i Male or female patients aged 18 to < 80 years inclusive, ii Patients presenting with withdrawal malfunction of a long-term venous access catheter which was functioning properly previously, according to patient or treating physician, iii No clear evidence of a non-thrombotic cause for catheter malfunction, iv Radiographic confirmation of a catheter thrombosis (only for stage I), v Negative urine pregnancy test (pregnancy test only required for females of child-bearing potential not using an accepted method of contraception), vi Written informed consent obtained from the patient prior to inclusion in the study OR if patient cannot read, written informed consent has been provided by an impartial witness.
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E.4 | Principal exclusion criteria |
i. Inability to inject into catheter, ii. Inability to perform peripheral venipuncture, iii. Known allergy to radiographic contrast-dye, iv. Active bleeding or known hemorrhagic diathesis, known thrombocytopenia (<30.000/µl) v. Open surgery, significant internal or gastrointestinal hemorrhage, or major trauma in previous 10 day period, vi. Currently being treated with vitamin K antagonist resulting in INR>2.0 at most recent measure (within past 48 hours) or with heparin/heparin-like agent resulting in an APTT>1.5 times normal calues (ULN at the hospital laboratory), vii. Any associated medical condition of which the investigator feels participation to this study protocol is contra-indicated. viii. (females only) pregnancy or lactation, parturition within the previous 30 days, ix. Participated in an investigational drug study within the past 30 days (concurrent participation in drug studies with medications approved in Belgium for any indication is allowed), x. Previously randomised into this trial xi. Stroke, intracranial trauma, or neurosurgery (intracranial, spinal) in the previous 3 months, xii. Significant arterial hypertension (SBP180 mm Hg and/or DBP110 mm Hg), xiii. Intracranial tumor, arteriovenous malformation, or aneurysm.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this trial is to evaluate the safety and efficacy of several dosing regimens of catheter-directed microplasmin. An attempt will be made to determine the dose or doses of microplasmin which achieve optimal efficacy after 1st treatment defined as catheter function restoration with acceptable safety in patients with radiographically-confirmed catheter thrombosis. |
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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 | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.1 | Randomised | No |
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 | Yes |
E.8.1.7.1 | Other trial design description |
first stage of the trial is open label second stage of the trial is randomised and placebo controll |
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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 | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |