Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
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|ClinicalTrials.gov Identifier: NCT01237340|
Recruitment Status : Terminated (The Sponsor voluntarily terminated this trial because compliance to strict Good Clinical Practice (GCP) requirements was not ensured - No safety concerns)
First Posted : November 9, 2010
Results First Posted : October 11, 2012
Last Update Posted : August 7, 2013
|Condition or disease||Intervention/treatment||Phase|
|Growth Hormone Deficiency (GHD)||Drug: Saizen®||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||59 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD)|
|Study Start Date :||October 2010|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
- Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen® [ Time Frame: Baseline up to Week 26 ]Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.
- Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen® [ Time Frame: Baseline up to Week 26 ]Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency.
- Insulin-like Growth Factor-I (IGF-1) Levels [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 ]
- Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 ]Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1.
- Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 ]
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to 28 days after last dose of study treatment ]Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks [28 days] after the final administration of Saizen® solution for injection).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01237340
|United States, Massachusetts|
|US Medical Information, Massachusetts, United States|
|Study Director:||Medical Responsible||Merck Serono S.A., Geneva|