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A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Sponsor: Ascendis Pharma Endocrinology Division A/S
Summary
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 Armenia, Australia, Belarus, Bulgaria, Georgia, Greece, Italy, New Zealand, Poland, Romania, Russia, Turkey, Ukraine, and the United States.
Official title: A Multicenter, Phase 3, Randomized, Open-label, Active-controlled, Parallel-group Trial Investigating the Safety, Tolerability, and Efficacy of TransCon hGH Administered Once a Week Versus Standard Daily hGH Replacement Therapy Over 52 Weeks in Prepubertal Children With Growth Hormone Deficiency (GHD)
Key Details
Gender
All
Age Range
3 Years - 12 Years
Study Type
INTERVENTIONAL
Enrollment
162
Start Date
2016-12-13
Completion Date
2019-01-17
Last Updated
2026-07-07
Healthy Volunteers
No
Conditions
Interventions
Once weekly subcutaneous injection of TransCon hGH
Once weekly subcutaneous injection
Once daily subcutaneous injection of Genotropin
Once daily subcutaneous injection
Locations (53)
Ascendis Pharma Investigational Site
Birmingham, Alabama, United States
Ascendis Pharma Investigational Site
Little Rock, Arkansas, United States
Ascendis Pharma Investigational Site
Los Angeles, California, United States
Ascendis Pharma Investigational Site
Orange, California, United States
Ascendis Pharma Investigational Site
Centennial, Colorado, United States
Ascendis Pharma Investigational Site
Jacksonville, Florida, United States
Ascendis Pharma Investigational Site
Orlando, Florida, United States
Ascendis Pharma Investigational Site
Saint Paul, Minnesota, United States
Ascendis Pharma Investigational Site
Jackson, Mississippi, United States
Ascendis Pharma Investigational Site
Lebanon, New Hampshire, United States
Ascendis Pharma Investigational Site
Mineola, New York, United States
Ascendis Pharma Investigational Site
Oklahoma City, Oklahoma, United States
Ascendis Pharma Investigational Site
Portland, Oregon, United States
Ascendis Pharma Investigational Site
Dallas, Texas, United States
Ascendis Pharma Investigational Site
Fort Worth, Texas, United States
Ascendis Pharma Investigational Site
Tacoma, Washington, United States
Ascendis Pharma Investigational Site
Yerevan, Armenia
Ascendis Pharma Investigational Site
Clayton, Australia
Ascendis Pharma Investigational Site
Minsk, Belarus
Ascendis Pharma Investigational Site
Varna, Bulgaria
Ascendis Pharma Investigational Site
Tbilisi, Georgia
Ascendis Pharma Investigational Site
Tbilisi, Georgia
Ascendis Pharma Investigational Site
Tbilisi, Georgia
Ascendis Pharma Investigational Site
Athens, Greece
Ascendis Pharma Investigational Site
Milan, Italy
Ascendis Pharma Investigational Site
Roma, Italy
Ascendis Pharma Investigational Site
Grafton, New Zealand
Ascendis Pharma Investigatonal Site
Gdansk, Poland
Ascendis Pharma Investigational Site
Warsaw, Poland
Ascendis Pharma Investigational Site
Iași, Romania
Ascendis Pharma Investigational Site
Izhevsk, Russia
Ascendis Pharma Investigational Site
Kazan', Russia
Ascendis Pharma Investigational Site
Krasnoyarsk, Russia
Ascendis Pharma Investigational Site
Moscow, Russia
Ascendis Pharma Investigational Site
Moscow, Russia
Ascendis Pharma Investigational Site
Nizhny Novgorod, Russia
Ascendis Pharma Investigational Site
Novosibirsk, Russia
Ascendis Pharma Investigational Site
Omsk, Russia
Ascendis Pharma Investigational Site
Saint Petersburg, Russia
Ascendis Pharma Investigational Site
Saint Petersburg, Russia
Ascendis Pharma Investigational Site
Samara, Russia
Ascendis Pharma Investigational Site
Saratov, Russia
Ascendis Pharma Investigational Site
Tomsk, Russia
Ascendis Pharma Investigational Site
Ufa, Russia
Ascendis Pharma Investigational Site
Vologda, Russia
Ascendis Pharma Investigational Site
Voronezh, Russia
Ascendis Pharma Investigational Site
Izmir, Turkey (Türkiye)
Ascendis Pharma Investigational Site
Melikgazi, Turkey (Türkiye)
Ascendis Pharma Investigational Site
Trabzon, Turkey (Türkiye)
Ascendis Pharma Investigational Site
Kharkiv, Ukraine
Ascendis Pharma Investigational Site
Kyiv, Ukraine
Ascendis Pharma Investigational Site
Kyiv, Ukraine
Ascendis Pharma Investigational Site
Odesa, Ukraine