NCT01237340

Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study

A Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 59 (actual)
• Sponsor: EMD Serono · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Growth Hormone Deficiency (GHD)

Interventions

Type	Name	Description
DRUG	Saizen®	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.

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2010-11-09
• Last updated: 2013-08-07
• Results posted: 2012-10-11

Locations

1 site across 1 country: United States