drugset / Trial / NCT01806298

An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid Formulation of Saizen® in Subjects With Adult Growth Hormone Deficiency (AGHD)

NCT01806298

Phase 4 Completed 78 enrolled Merck KGaA, Darmstadt, Germany
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2013-06
Primary completion
2016-03
Completion
2016-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Somatropin Protein / enzyme biologic Subcutaneous

Indications