A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

Completed · Phase 3

Conditions studied: Growth Hormone Deficiency, Pediatric, hGH (Human Growth Hormone), Endocrine System Diseases, Hormones, Pituitary Diseases

In brief

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.

Key facts

Study ID

NCT02781727

Run by

Ascendis Pharma Endocrinology Division A/S

People needed

162

Starts

2016-12-13

Expected to finish

2019-01-17

Last updated by the study team

2026-07-07

Who can join

Age: 3 and older, up to 12. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prepubertal children with GHD (either isolated or as part of a multiple pituitary hormone deficiency) in Tanner stage 1 (Tanner 1982) aged:
• Boys: 3-12 years, inclusive
• Girls: 3-11 years, inclusive
• Impaired height (HT) defined as at least 2.0 standard deviations (SD) below the mean height for chronological age and sex (HT SDS ≤ -2.0) according to the 2000 CDC Growth Charts for the United States Methods and Development, available at http://www.cdc.gov/growthcharts/
• Diagnosis of GHD confirmed by 2 different GH stimulation tests, defined as a peak GH level of ≤10 ng/mL, determined with a validated assay
• Bone age (BA) at least 6 months less than chronological age
• Baseline IGF-1 level of at least 1 SD below the mean IGF-1 level standardized for age and sex (IGF-1 SDS ≤-1)
• Written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is able to read, understand, and sign)

You may not qualify if…

• Children with a body weight below 12 kg
• Prior exposure to recombinant hGH or IGF-1 therapy
• Children with past or present intracranial tumor growth as confirmed by a sellar MRI scan (with contrast) at Screening (MRI results from up to 6 months prior to Screening may be accepted)
• Children with psychosocial dwarfism
• Children with idiopathic short stature
• History or presence of malignant disease; any evidence of present tumor growth
• Closed epiphyses
• Major medical conditions and/or presence of contraindication to hGH treatment
• Participation in any other trial of an investigational agent within 3 months prior to Screening

Where it is running

• 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 — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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