An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)
|ClinicalTrials.gov Identifier: NCT01806298|
Recruitment Status : Completed
First Posted : March 7, 2013
Results First Posted : April 4, 2017
Last Update Posted : December 2, 2017
|Condition or disease||Intervention/treatment||Phase|
|Adult Growth Hormone Deficiency||Drug: Saizen® solution for injection (referred as Saizen®)||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Open-label, Single-arm, Phase IV, Multicenter Trial to Explore the Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)|
|Study Start Date :||June 2013|
|Primary Completion Date :||March 2016|
|Study Completion Date :||March 2016|
Drug: Saizen® solution for injection (referred as Saizen®)
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®.
- 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.
- Number of Subjects With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, TEAEs Leading to Death, TEAEs Leading to Discontinuation [ Time Frame: Baseline up to Week 41 ]An adverse event (AE) was defined as any untoward medical occurrence in a subject which does not necessarily have a causal relationship with the study drug. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug or worsening of pre-existing medical condition, whether or not related to study drug. A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are those events with onset dates occurring during the on-treatment period or if the worsening of an event is during the on-treatment period. TEAEs include both Serious TEAEs and non-serious TEAEs.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01806298
|Australia, South Australia|
|Adelaide, South Australia, Australia, 5041|
|Australia, Western Australia|
|Perth, Western Australia, Australia, 6009|
|Clayton, Australia, 3168|
|Darlinghurst, Australia, 2010|
|Fitzroy, Australia, 3065|
|Berlin, Germany, 13344|
|Oldenburg, Germany, 26122|
|Würzburg, Germany, 97080|
|Goteborg, Sweden, 41345|
|Stockholm, Sweden, 17176|
|Birmingham, United Kingdom|
|Cleveland, United Kingdom, TS4 3BW|
|Guildford, United Kingdom, GU2 7XX|
|Liverpool, United Kingdom, L69 3PX|
|Manchester, United Kingdom, M20 4BX|
|Manchester, United Kingdom, M6 8HD|
|Norfolk, United Kingdom, PE30 4ET|
|Oxford, United Kingdom, OX3 7LJ|
|Truro, United Kingdom, TR1 3LJ|
|Study Director:||Medical Director||Merck KGaA|