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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
298
Once weekly subcutaneous injection of TransCon hGH
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
Number of Subjects With Treatment-Emergent Adverse Events [Long-Term Safety and Tolerability]
Long-term safety and tolerability of weekly lonapegsomatropin (TransCon hGH) treatment
Time frame: Up to Week 208
Annualized Height Velocity by Visit
Annualized height velocity (AHV) by visit with long-term dosing of weekly lonapegsomatropin treatment
Time frame: Up to Week 208
IGF-1 SDS by Visit
Insulin-like Growth Factor-1 (IGF-1) standard deviation score (SDS) by visit with long-term dosing of weekly lonapegsomatropin treatment at Week 13, Week 52, Week 104, Week 156, and Week 208. IGF-1 SDS is the number of standard deviations above or below the mean IGF-1 level for a child of the same age and sex. The target range for IGF-1 SDS was 0 to +2. An IGF-1 SDS of 0 represents the population mean. If the IGF-1 SDS is \< 0, then the negative score indicates an IGF-1 below the mean IGF-1 for a child of the same age and sex. If the IGF-1 SDS is \> 0, then the positive score indicates an IGF-1 above the mean IGF-1 for a child of the same age and sex. A positive score of IGF-1 SDS indicates a better outcome.
Time frame: Up to Week 208
Height SDS - Change From Baseline
Change in Height Standard Deviation Score (SDS) from baseline with long-term dosing of weekly lonapegsomatropin treatment at Week 13, Week 52, Week 104, Week 156, and Week 208. Height SDS is the number of standard deviations above or below the mean height for age and sex. A Standard Deviation Score of 0 equals the population mean. If the Height SDS is \< 0, then the negative score indicates a height below the mean height for a child of the same age and sex. If the Height SDS is \> 0, then the positive score indicates a height above the mean height for a child of the same age and sex. A positive change from baseline in Height SDS indicates improved outcomes.
Time frame: Up to Week 208
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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
...and 32 more locations