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Serono Completes Phase III Trial of its Drug to Treat HARS

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Serono has completed its Phase III double-blind, placebo-controlled trial of the company’s recombinant human growth hormone in the treatment of HIV-associated Adipose Redistribution Syndrome (HARS), which met all primary and major secondary endpoints. Serono plans to submit the file to the FDA in the first half of this year and expects that the data will be presented at upcoming scientific meetings.

More than 300 patients enrolled in the trial to determine if daily administration of r-hGH as treatment for the abnormal fat accumulation and distribution associated with HARS reduces Visceral Adipose Tissue (VAT) more effectively than placebo. In the first phase of the study, patients were randomly assigned to receive either r-hGH 4 mg daily, or placebo. In the second placebo-controlled phase of the study, r-hGH was administered as 2 mg on alternate days for 24 weeks to assess the ability of a maintenance regimen to sustain improvements in VAT.

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