Completed
PHASE4
INTERVENTIONAL
NCT01806298
An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
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.
Interventions
Name:
Saizen® solution for injection (referred as Saizen®)
Type:
DRUG
Description:
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®.
Primary Outcomes
Measure:
Percentage of Subjects Developing Binding Antibodies (BAbs) to Saizen®
TimeFrame:
Baseline up to Week 39
Description:
Percentage of subjects developing BAbs = (Number of BAb positive subjects / Total number of subjects) x 100.
Trial Information
NCT ID
NCT01806298
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE4
Sponsor
Merck KGaA, Darmstadt, Germany
Last Updated
December 15, 2025