An Open-label Phase 4 Study to Explore Immunogenicity of the Liquid

Clinical Trial 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.

See also
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Completed	`NCT00297713` - Study of an Extended-Release, Crystalline Formulation of Recombinant Human Growth Hormone (ALTU-238) in Growth Hormone Deficient Adults to Determine Pharmacokinetics, Pharmacodynamics, and Drug Safety	Phase 2
Completed	`NCT01543880` - Safety and Efficacy of Long-term Somatropin Treatment in Adults	N/A
Completed	`NCT01580605` - French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin
Not yet recruiting	`NCT04867317` - Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)	Phase 3

NCT number	NCT01806298
Study type	Interventional
Source	Merck KGaA
Contact
Status	Completed
Phase	Phase 4
Start date	June 2013
Completion date	March 2016

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms