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The U.S. Food and Drug Administration has granted the South Texas Blood & Tissue Center (STBTC) approval to manufacture and distribute cold-stored platelets with a shelf life of 14 days for the treatment of actively bleeding patients when conventional platelets are not available, or their use is not practical.
Platelets are a key blood component constantly in demand for treating severe bleeding, for example in trauma and maternal hemorrhage patients.
The primary objective of this study is to evaluate the effect of OCA compared to placebo on histological improvement in nonalcoholic steatohepatitis (NASH) by assessing the following primary endpoints using NASH Clinical Research Network (CRN) scoring criteria: Improvement in fibrosis by at least 1 stage with no worsening of NASH, or Resolution of NASH with no worsening fibrosis