Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®
| Group | Value (percentage of subjects) |
|---|---|
| Saizen® | 0 |
Trial · Interventional
CompletedPhase 4Results postedRegistry dataAustralia, Germany, Sweden, United Kingdom
1 trial · 1 completed · 1 with posted results
An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)
NCT01806298Jun 2013 to Mar 2016
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Experimental
Saizen®
Outcomes the sponsor listed as primary.
Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®
Time frame · Baseline up to Week 39
Percentage of subjects developing BAbs = (Number of BAb positive subjects / Total number of subjects) x 100.
Percentage of Subjects With Binding Antibodies (BAbs) Who Became Positive for Neutralizing Antibodies (NAbs)
Time frame · Baseline up to Week 39
Percentage of subjects with BAbs who become positive for NAbs = (Number of NAb positive subjects / Number of BAbs positive subjects) x 100
Insulin-like Growth Factor-I (IGF-I) Levels
Time frame · Baseline, Week 2, 8, 16, 29, 39 and 41
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 \[AGHD\]).
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels
Time frame · Baseline, Week 2, 8, 16, 29, 39 and 41
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 \[AGHD\])
Insulin-like Growth Factor-I Standard Deviation Score (IGF-I SDS)
Time frame · Baseline, Week 2, 8, 16, 29, 39 and 41
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.
Treatment Adherence Rate as Documented Using EasypodTM Connect
Time frame · Week 2, 8, 16, 29 and 39
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.
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
| Group | Value (percentage of subjects) |
|---|---|
| Saizen® | 0 |
| Group | Value |
|---|---|
| Saizen® | not posted |
| Group | Value (nanomoles per liter (nmol/L)) | Spread |
|---|---|---|
| Saizen® | 14.54 | 7.219 |
| Group | Value (milligram/liter (mg/L)) | Spread |
|---|---|---|
| Saizen® | 2.62 | 0.843 |
| Group | Value (Standard deviation score) | Spread |
|---|---|---|
| Saizen® | -3.27 | 0.816 |
| Group | Value (percentage of treatment adherence) | Spread |
|---|---|---|
| Saizen® | 89.3 | 13.35 |
| Group | Value (Participants) |
|---|---|
| Saizen® | 72 |
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Saizen®Saizen® solution for injection was administered subcutaneously once daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®. | – | 4 / 78 | 65 / 78 |
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