A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency

Completed · Phase 3

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

In brief

A 26 week trial of TransCon hGH, a long-acting growth hormone product, administered once-a-week. Approximately 150 children (males and females) with growth hormone deficiency (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, Canada, Australia, and New Zealand.

Key facts

Study ID

NCT03305016

Run by

Ascendis Pharma Endocrinology Division A/S

People needed

146

Starts

2017-11-13

Expected to finish

2019-03-19

Last updated by the study team

2026-07-07

Who can join

Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Investigator-determined GHD diagnosis prior to the historical initiation of daily hGH therapy.
• 6 months to 17 years old, inclusive, at Visit 1
• If 3 to 17 years old, are taking daily hGH at a dose of ≥ 0.20 mg hGH/kg/week for at least 13 weeks but no more than 130 weeks prior to Visit 1
• If ≥ 6 months but < 3 years old, are either hGH treatment-naïve or are taking daily hGH at a dose of ≥ 0.20mg hGH/kg/week for no more than 130 weeks prior to Visit 1
• Tanner stage < 5 at Visit 1
• Open epiphyses (bone age ≤14.0 years for females or ≤16.0 years for males)
• 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…

• Weight of < 5.5 kg or > 80 kg at Visit 1
• Females of child-bearing potential
• History of malignant disease
• Any clinically significant abnormality likely to affect growth or the ability to evaluate growth (eg, chronic diseases or conditions such as renal insufficiency, spinal cord irradiation, hypothyroidism, active celiac disease, malnutrition or psychosocial dwarfism)
• Poorly-controlled diabetes mellitus (HbA1c >8.0%) or diabetic complications
• Known neutralizing antibodies against hGH
• Major medical conditions, unless approved by Medical Monitor
• Pregnancy
• Presence of contraindications to hGH treatment
• Likely to be non-compliant with respect to trial conduct (in regards to the subject and/or the parent/legal guardian/caregiver)
• Participation in any other trial of an investigational agent within 30 days prior to Visit 1
• Prior exposure to investigational hGH

Where it is running

• University of Alabama — Birmingham, Alabama, United States
• Neufeld Medical Group Inc. — Los Angeles, California, United States
• Center of Excellence in Diabetes and Endocrinology — Sacramento, California, United States
• Rocky Mountain Pediatric Endocrinology — Centennial, Colorado, United States
• Nemours Children's Health System — Jacksonville, Florida, United States
• Orlando Health Inc. — Orlando, Florida, United States
• Tallahassee Memorial Hospital — Tallahassee, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Children's Minnesota — Saint Paul, Minnesota, United States
• University of Mississippi Medical Center — Jackson, Mississippi, United States
• Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
• NYU Winthrop Hospital — Mineola, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• University of Oklahoma Health Sciences Center — Oklahoma City, Oklahoma, United States
• Children's Diabetes and Endocrine Center — Portland, Oregon, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Children's Medical Center — Dallas, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• University of Virginia Children's Hospital — Charlottesville, Virginia, United States
• Children's Hospital of The King's Daughters — Norfolk, Virginia, United States
• Monash Children's Hospital — Clayton, Victoria, Australia
• Stollery Children's Hospital — Edmonton, Alberta, Canada
• The Liggins Institute, The University of Auckland — Grafton, Auckland, New Zealand

Full record on ClinicalTrials.gov

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