Date: 2015-07-10
Type of information: Completion of patient enrollment
phase: 3
Announcement: completion of patient enrollment
Company: Opko Health (USA - Fl)
Product: long-acting recombinant human growth hormone analog (Mod-4023)
Action
mechanism: protein.
Disease: adult growth hormone deficiency
Therapeutic area: Genetic diseases - Endocrine diseases - Hormonal diseases
Country: USA
Trial
details: This phase 3 study will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).(NCT01909479)
Latest
news: * On July 10, 2015, Opko Health has completed enrollment in the single pivotal Phase 3 trial of its long acting human growth hormone (hGH-CTP) in growth hormone deficient (GHD) adults. The trial is designed to 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 trial is a randomized, double-blind, placebo-controlled, multi-center, global study in adults with GHD. The study is divided into two treatment periods: a 26-week, double-blind, placebo-controlled period, followed by a 26-week, open-label extension. The study is expected to end toward the second half of 2016; regulatory submission will follow study completion.
