CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 174 enrolled
Drug / intervention
Plasmin +2 morebiological
Likely dose
Not stated in 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/NCT01222117
NCT01222117Phase 2Completed
CompareCT.gov

A Phase 2, Randomized, Open-label (With Blinded Plasminogen Activator and Placebo Control Groups) Study to Evaluate the Effects of Different Intra-thrombus Infusion Regimens of Plasmin (Human) Compared to Plasminogen Activator and Placebo In Patients With Acute Lower Extremity Native Artery or Bypass Graft Occlusion

Grifols Therapeutics LLC·interventional·Posted Oct 18, 2010·Updated Jan 16, 2017

In Brief

A Phase 2 clinical trial evaluating Plasmin, Plasminogen Activator, and 1 other intervention for Acute Peripheral Arterial Occlusion. Completed, enrolled 174 participants across 39 sites in 12 countries.

Detailed Summary

The primary purpose of this Phase 2 study is to optimize Plasmin delivery by comparing different delivery regimens in patients with peripheral arterial occlusion. The study includes a blinded plasminogen activator treatment group and a blinded plasminogen activator placebo group. The study will also assess safety and tolerability of Plasmin at 150 and 250 mg doses.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Peripheral Arterial Occlusion
CountriesBelgium, Bulgaria, Czechia, Germany, India, Peru, Poland, Romania, Serbia, Slovakia, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 18, 2010
Enrollment StartDec 1, 2010
Primary CompletionDec 1, 2015
Study CompletionJan 1, 2016
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 15.7 years ago

Interventions

Plasminbiological

Plasmin prepared in 0.9% saline for injection

Plasminogen Activatorbiological

Plasminogen activator used according to the Investigator's clinical judgment.

Placeboother

Normal saline for injection at the same volume as the plasminogen activator.