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)

NCT01237340 Phase 3 TERMINATED Results posted

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

Details

Lead sponsor	EMD Serono
Phase	Phase 3
Status	TERMINATED
Enrolment	59
Start date	2010-10
Completion	2011-12

Conditions

• Growth Hormone Deficiency (GHD)

Interventions

• Saizen®

Primary outcomes

• Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen® — Baseline up to Week 26
  Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.

Countries

United States