A Long-Term Trial Investigating Safety and Efficacy of TransCon hGH in Children With Growth Hormone Deficiency Who Have Completed a Prior TransCon hGH Clinical Trial

Completed · Phase 3

Conditions studied: Growth Hormone Deficiency, Pediatric, Endocrine System Diseases, Hormone Deficiency, Pituitary Diseases

In brief

A multicenter, phase 3, long-term extension trial of TransCon hGH administered once-weekly in children with growth hormone deficiency (GHD) who previously participated in a phase 3 TransCon hGH trial. Approximately 300 children (males and females) with GHD will be included. All study participants will receive TransCon hGH. This is a global trial that will be conducted in, but not limited to, the United States, Poland, Bulgaria, Ukraine, Armenia, Russia and Australia.

Key facts

Study ID

NCT03344458

Run by

Ascendis Pharma A/S

People needed

298

Starts

2017-12-19

Expected to finish

2023-02-21

Last updated by the study team

2026-07-07

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children who have completed a prior phase 3 TransCon hGH trial
• Children who have not permanently discontinued study drug in the prior trial
• Written, signed, informed consent of the parent or legal guardian of the subject and written assent of the subject as required by the IRB/HREC/IEC

You may not qualify if…

• Poorly-controlled diabetes mellitus (HbA1c ≥ 8.0%) or diabetic complications
• Evidence of closed epiphyses, defined as bone age > 14.0 years for females or > 16.0 years for males
• Major medical conditions unless approved by Medical Expert
• Known hypersensitivity to the components of the trial medication
• Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver)
• Pregnancy
• Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule

Where it is running

• Ascendis Pharma Investigational Site — Birmingham, Alabama, United States
• Ascendis Pharma Investigational Site — Los Angeles, California, United States
• Ascendis Pharma Investigational Site — Orange, California, United States
• Ascendis Pharma Investigational Site — Sacramento, 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 — Tallahassee, 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 — New York, New York, United States
• Ascendis Pharma Investigational Site — Cleveland, Ohio, United States
• Ascendis Pharma Investigational Site — Oklahoma City, Oklahoma, United States
• Ascendis Pharma Investigational Site — Portland, Oregon, 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 — Charlottesville, Virginia, United States
• Ascendis Pharma Investigational Site — Norfolk, Virginia, United States
• Ascendis Pharma Investigational Site — Tacoma, Washington, United States
• Ascendis Pharma Investigational Site — Yerevan, Armenia
• Ascendis Pharma Investigational Site — Clayton, Victoria, Australia
• Ascendis Pharma Investigational Site — Minsk, Belarus

Full record on ClinicalTrials.gov

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