A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency (NCT03305016) | Clinical Trial Compass
CompletedPhase 3
A Safety, Tolerability and Efficacy Study of TransCon hGH in Children With Growth Hormone Deficiency
United States146 participantsStarted 2017-11-13
Plain-language summary
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.
Who can participate
Age range6 Months – 17 Years
SexALL
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Inclusion criteria
✓. 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
Exclusion criteria
✕. 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
What they're measuring
1
Number of Participants With Treatment-Emergent Adverse Events [Safety and Tolerability]