drugset / Trial / NCT01305226

A Trial Using Double-Bolus THR-100 Versus Streptokinase

NCT01305226

Phase 3 Completed 120 enrolled Bharat Biotech International Limited
RandomizedParallel-groupOpen-labelTreatment

Summary

This novel fibrinolytic agent is a 136 amino acid single chain protein secreted by some strains of Staphylococcus aureus and readily produced by recombinant DNA technology. Two natural variants of recombinant staphylokinase, THR-100 and SakSTAR, have been developed for investigational use in preliminary trials. Like SK, it forms an equimolar complex with plasmin which in turn activates plasminogen to plasmin. Unlike SK, the complexed, activated molecule (which undergoes proteolytic cleavage of the first ten amino acids to generate active staphylokinase) has a high degree of fibrin-selectivity in a human plasma milieu. This fibrin-selectivity is due in large measure to potent activation at the clot surface by trace amounts of plasmin, and rapid inactivation of the circulating complex by antiplasmin. Hence, it provides an interesting and promising alternative therapy.

Timeline

Start
2010-10
Primary completion
2011-08
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Streptokinase Protein / enzyme biologic 1.5e+06 iu Intravenous
Subject THR100 Protein / enzyme biologic 15 mg Intravenous