Study to assess the immunogenecity of Saizen in adults with GHD

• Research type

  Research Study

• Full title

  A phase IIIb, open-label, single-arm, multicenter study to assess the immunogenicity of the r-hGH liquid multidose formulation (Saizen solution for injection) when administered to male and female adults with documented growth hormone deficiency (GHD)

• IRAS ID

  71962

• Contact name

  Tara Kearney

• Sponsor organisation

  Merck Serono S.A.

• Eudract number

  2010-023430-23

• Research summary

  A Phase IIIb, open-label, single-arm, multicenter, safety study to assess the immunogenicity of multidose liquid r-hGH (Saizen solution for injection) in growth hormone (GH)-deficient adult subjects including(i) GH-naÇîve subjects; (ii) subjects who had undergone treatment with the freeze-dried formulation of Saizen for pediatric Growth Hormone deficiency (GHD); and (iii) adult GHD (AGHD) subjects who either: (a) discontinued Saizen freeze-dried treatment for reasons other than safety, tolerability, or efficacy; or (b) are currently treated with Saizen freeze-dried for at least 3 consecutive months immediately prior to Screening. This study is exploratory in nature and will investigate the immunogenicity of Saizen solution for injection. The duration of treatment will be 6 months (26 weeks), and subjects will undergo single, daily subcutaneous (SC) injections of Saizen solution for injection, preferably at bedtime. The study will also assess the safety of the liquid r-hGH formulation in the study participants via Treatment-Emergent-Adverse-Event (TEAE), vital signs, physical examinations, and laboratory results, including GH biomarkers.

• REC name

  Scotland A REC

• REC reference

  11/AL/0062

• Date of REC Opinion

  28 Mar 2011

• REC opinion

  Further Information Favourable Opinion