drugset / Trial / NCT01253512

Study to Assess the Safety and Efficacy of THR-18 When Administered to Patients Suffering Acute Ischemic Stroke and Treated With Tissue Plasminogen Activator (tPA)

NCT01253512 ↗

Phase 1/2 Unknown 22 enrolled Thrombotech Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This will be a randomized, double-blind, placebo-controlled, multi-center, multi-national, escalating dose, pilot study comparing two doses of THR-18 to placebo when administered to patients suffering acute ischemic stroke and treated with Tissue Plasminogen Activator (tPA). The study hypothesis is that THR-18 will be safe and well tolerated in subjects suffering acute ischemic stroke and treated with Thrombolysis.

Timeline

Start
2011-03
Primary completion
2011-12
Completion
2011-12

Drugs

EvaluationDrugModalityDoseRoute
Subject THR-18 Peptide 0.25 mg/kg —
Subject THR-18 Peptide 0.5 mg/kg —

Indications