Date: 2011-02-07
Type of information:
phase: 3
Announcement: initiation of the trial
Company: ThromboGenics (Belgium) Bharat Biotech International (India)
Product: THR-100 (Staphylokinase)
Action mechanism: thrombolytic agent
Disease: acute myocardial infarction
Therapeutic area: Cardiovascular diseases
Country: India
Trial details: ThromboGenics has announced that its partner, Bharat Biotech International Ltd has initiated a Phase III trial in India with THR-100 in patients suffering an acute myocardial infarction (AMI or heart attack). The trial is expected to recruit approximately 120 patients.Bharat Biotech anticipates that the Phase III trial with THR-100 will be completed in the second half of 2011. The results of this Phase III trial will pave the way for this novel thrombolytic to be filed for marketing approval by Bharat Biotech with Indian regulatory authorities.
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