Conditions: Adult Growth Hormone Deficiency
Keywords: Adult Growth hormone deficiency Saizen® Recombinant human growth hormone (r-hGH) Somatropin
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 78
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: None

Interventions: intervention 1: Saizen® solution for injection (referred as Saizen®)
Intervention descriptions: intervention 1: 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®.

Protocol document: