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news.Swedish Orphan Biovitrum has recruited first patient in a double-blind, multicenter, placebo-controlled Phase III trial to investigate the safety, tolerability and efficacy of Kiobrina (rhBSSL) in the treatment of preterm infants.
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The company expects to recruit patients in 70 centers in 11 European nations.
In the trial, the preterm infants younger than 32 weeks of gestational age are randomized to receive rhBSSL or placebo added to preterm formula or pasteurized human milk for 4 weeks to demonstrate improved growth velocity.
The combined results from two Phase II studies evaluating Kiobrina demonstrated increase in growth velocity and uptake of long chain polyunsaturated fatty acids such as docosahexanoic acid and arachidonic acid (omega-3 and omega-6 fatty acids).