Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
This study has been terminated.
(The Sponsor voluntarily terminated this trial because compliance to strict Good Clinical Practice (GCP) requirements was not ensured - No safety concerns)
Information provided by (Responsible Party):
First received: November 5, 2010
Last updated: August 4, 2013
Last verified: August 2013
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
Resource links provided by NLM:
Genetics Home Reference related topics: combined pituitary hormone deficiency isolated growth hormone deficiency Meier-Gorlin syndrome metatropic dysplasia pseudoachondroplasiaU.S. FDA Resources
Further study details as provided by EMD Serono:
Primary Outcome Measures:
- Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen® [ Time Frame: Baseline up to Week 26 ] [ Designated as safety issue: No ]Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.
Secondary Outcome Measures:
- Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen® [ Time Frame: Baseline up to Week 26 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]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 ] [ Designated as safety issue: Yes ]
- Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to 28 days after last dose of study treatment ] [ Designated as safety issue: Yes ]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).
|Study Start Date:||October 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
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.
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