Terminated
PHASE3
INTERVENTIONAL
NCT01237340
SaizenĀ® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
To assess the immunogenicity of SaizenĀ® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).
Interventions
Name:
SaizenĀ®
Type:
DRUG
Description:
Single dose of SaizenĀ® (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 SaizenĀ® (freeze-dried formulation), based on locally approved product labeling.
Primary Outcomes
Measure:
Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to SaizenĀ®
TimeFrame:
Baseline up to Week 26
Description:
Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (SaizenĀ®), irrespective of their binding site.
Trial Information
NCT ID
NCT01237340
Status
Terminated
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
EMD Serono
Last Updated
December 15, 2025