This is a Phase IV, multicenter, open-label, single-arm study of somatropin (rDNA origin) (Nutropin AQ v1.1) in pre-pubertal children with growth hormone deficiency (GHD) naïve to prior recombinant human growth hormone (rhGH) treatment. The study is designed to characterize the immunogenicity profile of somatropin (rDNA origin) injection when administered daily subcutaneously for 12 months. The clinical impact of immunogenicity will also be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
82
Somatropin will be administered as SC injections at a dose of up to 0.043 mg/kg/day. The dose may be adjusted for a change in body weight of at least (plus \[+\]/minus \[-\]) 2 kilograms (kg) from baseline at the Month 6 study visit or for a change in insulin-growth factor-1 (IGF-1), as per investigator assessment.
Arkansas Children's Hospital Research Institute
Little Rock, Arkansas, United States
Children'S Hospital of Orange County
Orange, California, United States
Center of Excellence in Diabetes & Endocrinology
Sacramento, California, United States
San Diego Medical Group; Pediatric Endocrinology
San Diego, California, United States
Rocky Mountain Pediatric Endocrinology, PC
Centennial, Colorado, United States
Percentage of Participants Who Develop Anti-GH Antibodies After Treatment With Nutropin AQ v1.1
Participants who were tested positive to anti-GH antibody after initiation of study treatment.
Time frame: Baseline up to 1 year
Percentage of Participants Who Exhibit Functional Growth Attenuation
Growth attenuation is defined as initial growth response greater than pretreatment velocity followed by reduction in growth response to below the pretreatment velocity in the subsequent 6- to 12-month treatment period or reaching ≤ 2 cm per year.
Time frame: Baseline up to 1 year
Percentage of Participants With Neutralizing Antibodies
Among participants who developed positive anti-GH antibody post-baseline, participants who were tested positive to neutralizing anti-GH antibody during study participation.
Time frame: Baseline up to 1 year
Annualized Growth Velocity at Months 6 and 12 (Change From Baseline)
Annualized growth velocity is defined as (height - baseline height) / (date of height assessment - date of baseline)\*365.25. Results are presented according to anti-GH antibody status (positive included all participants that were anti-GH antibody positive at least once post-baseline visit and anti-GH antibody negative population included all participants that were anti-GH antibody negative at all post-baseline visits).
Time frame: Months 6, 12
Height Standard Deviation Score (SDS) at Months 6 and 12 (Change From Baseline)
Height Standard Deviation Score (SDS) allows for the comparison of a participants height to that of others in the same age group. Therefore, the average height for that age group will have the SDS of 0. In this study, the starting Height SDS score was ≤ -1.5 (≤ 5th percentile). Results are presented according to anti-GH antibody status (positive included all participants that were anti-GH antibody positive at least once post-baseline visit and anti-GH antibody negative population included all participants that were anti-GH antibody negative at all post-baseline visits.
Time frame: Months 6, 12
Percentage of Participants With Adverse Events
Among participants who received at least one dose of study drug, those who reported at least one adverse event during study participation.
Time frame: Baseline up to 1 year
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Pediatric Endocrine Associates
Greenwood Village, Colorado, United States
Nemours Children's Clinic - of the Nemours Foundation
Jacksonville, Florida, United States
Miami Children's Hospital
Miami, Florida, United States
Nemours Childrens Clinic
Orlando, Florida, United States
The Pediatric Endocrine Office of Larry C. Deeb
Tallahassee, Florida, United States
...and 23 more locations