This is an open-label, single-arm, multicenter, Phase 4 study to explore the immunogenicity of the liquid formulation of Saizen® in subjects with Adult Growth Hormone Deficiency (AGHD), who are growth hormone (GH) treatment-naïve or who had prior GH treatment for GHD which was stopped at least 1 month prior to Screening and have no contraindication to the use of GH.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Saizen® solution for injection will be administered subcutaneously daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
Research site
Adelaide, South Australia, Australia
Research site
Perth, Western Australia, Australia
Research site
Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®
Percentage of subjects developing BAbs = (Number of BAb positive subjects / Total number of subjects) x 100.
Time frame: Baseline up to Week 39
Percentage of Subjects With Binding Antibodies (BAbs) Who Became Positive for Neutralizing Antibodies (NAbs)
Percentage of subjects with BAbs who become positive for NAbs = (Number of NAb positive subjects / Number of BAbs positive subjects) x 100
Time frame: Baseline up to Week 39
Insulin-like Growth Factor-I (IGF-I) Levels
Growth Hormone (GH) biomarker levels were summarized by GH treatment status at study entry (that is subjects were classified as GH treatment-naïve subjects or subjects with prior GH treatment for adult growth hormone deficiency \[AGHD\]).
Time frame: Baseline, Week 2, 8, 16, 29, 39 and 41
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels
Growth Hormone (GH) biomarker levels were summarized by GH treatment status at study entry (that is subjects were classified as GH treatment-naïve subjects or subjects with prior GH treatment for adult growth hormone deficiency \[AGHD\])
Time frame: Baseline, Week 2, 8, 16, 29, 39 and 41
Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS)
Insulin-like Growth Factor-1 SDS was calculated based on the actual value of IGF-1 minus reference value of IGF-1 divided by reference standard deviation of IGF-1. SDS indicated how many standard deviations higher (in case of positive SDS) or lower (in case of negative SDS) a subject's value was relative to the mean of the reference population. The scores were centered around zero. Negative score indicated that the IGF-I value was lower compared to the reference population.
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Clayton, Australia
Research site
Darlinghurst, Australia
Research site
Fitzroy, Australia
Research site
Berlin, Germany
Research site
Oldenburg, Germany
Research site
Würzburg, Germany
Research site
Gothenburg, Sweden
Research site
Stockholm, Sweden
...and 9 more locations
Time frame: Baseline, Week 2, 8, 16, 29, 39 and 41
Treatment Adherence Rate as Documented Using EasypodTM Connect
Treatment adherence rate was measured by: (total dose received divided by total dose prescribed) multiplied by 100. Saizen solution for injection was administered using the easypod device and treatment adherence information was obtained from the device using the easypod connect software.
Time frame: Week 2, 8, 16, 29 and 39