Date: 2016-08-11
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Ascendis Pharma (Denmark)
Product: TransCon Growth Hormone
Action
mechanism: hormone/proteine. TransCon Growth Hormone is a prodrug that releases unmodified growth hormone, thus maintaining the same mode of action as currently prescribed daily growth hormone therapies. Clinical studies of TransCon Growth Hormone have demonstrated a comparable efficacy, safety, tolerability and immunogenic profile to that of daily growth hormone.
Disease: growth hormone deficiency
Therapeutic area: Endocrine diseases - Hormonal diseases
Country: USA
Trial
details: This phase 3, randomized, open-label, active-controlled, parallel-group trial is a 52 week trial of TransCon hGH, a long-acting growth hormone product, versus human growth hormone therapy. TransCon hGH will be given once-a-week, human growth hormone (hGH) will be given daily. Approximately 150 prepubertal, hGH-treatment naïve children (males and females) with GHD will be included. Randomization will occur in a 2:1 ratio (TransCon hGH : Genotropin). This is a global trial that will be conducted in, but not limited to, the United States, Canada, Germany, France, Poland, Bulgaria, Russia and Australia. (NCT02781727)
Latest
news: * On November 30, 2016, Ascendis Pharma announced that the company has initiated enrollment in the global Phase 3 heiGHt Trial of TransCon Growth Hormone in children with growth hormone deficiency (GHD). This randomized, active-controlled heiGHt Trial aims to enroll 150 pediatric patients with GHD by the end of 2017. * On August 11, 2016, Ascendis Pharma announced the initiation of the global Phase 3 TransCon Growth Hormone heiGHt Trial in children with growth hormone deficiency (GHD). The heiGHt Trial initiation follows End-of-Phase 2 discussions with the FDA, as well as various discussions with regulatory agencies worldwide. The heiGHt trial is a randomized, open-label, active-controlled Phase 3 registration study that is designed to enroll approximately 150 children with GHD who have not previously been treated. Patients will receive either once-weekly TransCon Growth Hormone (0.24 mg/kg/week) or daily injections of Genotropin® at 34 µg/kg/day (0.24 mg/kg/week) with a 2:1 randomization in a non-inferiority design. The primary endpoint of the trial is height velocity after twelve months of treatment. Patients completing therapy may then enroll in a planned open-label extension study. Ascendis plans to conduct the trial at sites in North and South America, Europe, the Middle East, North Africa, and Oceania (Australia/New Zealand).
