CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Plasmin (Human) +2 morebiological
Likely dose
Plasmin (Human) 20 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01014975
NCT01014975Phase 2Completed
CompareCT.gov

A Phase 1/2a, Open Label, Dose Escalation, Safety Study of Intra-thrombus Plasmin (Human) Administration in Acute, Middle Cerebral Artery, Ischemic Stroke

Grifols Therapeutics LLC·interventional·Posted Nov 17, 2009·Updated Oct 21, 2015

In Brief

A Phase 2 clinical trial evaluating Plasmin (Human) for Acute Ischemic Stroke. Completed, enrolled 40 participants across 23 sites in 6 countries.

Detailed Summary

This study tests the drug, Plasmin (Human), in patients with a stroke due to a clot in the middle cerebral artery (MCA). Plasmin is an enzyme that causes clot lysis by cleaving a clot component, fibrin. In this study, Plasmin (Human) is administered locally through a catheter to the clot within 9 hours of the stroke onset. Three doses of Plasmin (Human) (20 mg, 40 mg, and 80 mg) are being tested in 3 different groups of patients. Patients are monitored by imaging of the affected artery and functional testing.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Ischemic Stroke
CountriesAustralia, Austria, France, Serbia, Slovakia, Spain
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 17, 2009
Enrollment StartNov 1, 2009
Primary CompletionNov 1, 2013
Study CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.6 years ago

Interventions

Plasmin (Human)biological

Plasmin (Human), 20 mg, delivered through a catheter into a thrombus

Plasmin (Human)biological

Plasmin (Human), 40 mg, delivered through a catheter into a thrombus

Plasmin (Human)biological

Plasmin (Human), 80 mg, delivered through a catheter into a thrombus