Conditions: Growth Hormone Deficiency (GHD)
Keywords: Adult Growth Hormone Deficiency (AGHD) immunogenicity growth hormone antibodies GH biomarkers IGF-I
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 59
Healthy volunteers: no

Brief summary:
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Saizen®
Intervention descriptions: intervention 1: 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.

Protocol document: