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news.OPKO Health has completed patient enrollment in the single pivotal Phase III trial of its long acting human growth hormone (hGH-CTP) in growth hormone deficient (GHD) adults.
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hGH-CTP is a new long-acting recombinant human growth hormone analog being developed by OPKO to treat children with growth failure due to inadequate endogenous growth hormone secretion, and adults with HD of either childhood or adult-onset etiology. hGH-CTP is intended to reduce the burden of daily injection therapy.
The randomized, double-blind, placebo-controlled, multi-center, global trial will evaluate the safety and efficacy of hGH-CTP with a primary endpoint of superiority compared to placebo in decreasing fat mass in adults with GHD.
The Phase III trial has been divided into two treatment periods a 26-week, double-blind, placebo-controlled period, followed by a 26-week, open-label extension.
For the development and commercialization of hGH-CTP, OPKO has a world-wide collaboration agreement with Pfizer.
Regulatory submission will be carried out after the completion of the study, which is expected to take place in the second half of next year.