Clinical Trial of Microplasmin in Patients with Long-Term Venous Access Catheter Thrombosis - Microplasmin for CVC thrombosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-003224-19-BE

Enrollment

Registered

2005-10-25

Start date

2005-10-04

Completion date

Unknown

Last updated

2025-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thrombotic occlusion of central venous access devices

Interventions

Product Name: microplasmin Product Code: µPL Pharmaceutical Form: Intravenous infusion Pharmaceutical form of the placebo: Intravenous infusion Route of administration of the placebo: Intravenous bolu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: i Male or female patients aged 18 to =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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 (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 (SBP?180 mm Hg and/or DBP?110 mm Hg), xiii. Intracranial tumor, arteriovenous malformation, or aneurysm.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate safety and efficacy of microplasmin in patients with long term venous access catheter thrombosis. ;Secondary Objective: Non;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.	—

Measure

Time frame

Main Objective: To evaluate safety and efficacy of microplasmin in patients with long term venous access catheter thrombosis. ;Secondary Objective: Non;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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Countries

Belgium

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026