Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
Condition: Growth Hormone Deficiency (GHD)
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Intervention: Saizen®
Intervention description: 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.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 59.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Adult Growth Hormone Deficiency (AGHD); immunogenicity; growth hormone; antibodies; GH biomarkers; IGF-I

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Adult male and female subjects, 18-60 years of age, inclusive, at the time the
             informed consent is signed

          -  Subjects who have confirmed adult GHD

          -  Subjects who are growth hormone (GH) treatment-naive or had received Saizen®
             (freeze-dried formulation) for pediatric GHD (PGHD), or are currently receiving
             Saizen® freeze-dried formulation for adult GHD (AGHD)

          -  Subjects who have binding antibody-negative (BAbs-) at screening

          -  Subjects who have no evidence of concomitant disease, intercurrent illness, or
             resultant therapy that would interfere with subject compliance, the evaluation of
             study results, or compromise the safety of the subject

          -  Female subjects of childbearing potential who have a negative serum pregnancy test at
             the screening visit (and at each scheduled visit during the study)

          -  Subjects who are willing to comply with the procedures of the study

          -  Subjects who are willing to sign an Independent Ethics Committee/Institutional Review
             Board approved informed consent form

          -  Other protocol-defined inclusion criteria may apply

        Exclusion Criteria:

          -  Subjects who are currently receiving or have previously received treatment for adult
             GHD or any other indication, including PGHD, with a commercial GH product other than
             Saizen® freeze-dried formulation

          -  Subjects who had a chronic underlying disease within 6 months prior to screening or
             concomitant medication(s) that in the opinion of the investigator would exclude the
             subject from the trial

          -  Subjects who have significant renal impairment

          -  Subjects who have diabetes mellitus

          -  Subjects who are immunosuppressed

          -  Subjects who have a current malignancy or a history of any malignancy (excluding
             fully-treated basal cell carcinoma)

          -  Subjects who have participated in another study and received an investigational drug
             within 30 days prior to screening visit

          -  Subjects who have clinically significant abnormal laboratory value(s)

          -  Subjects who have known hypersensitivity or allergy to exogenous human GH or any of
             the excipients or phenol, the bacteriostatic agent in the Saizen® solution for
             injection

          -  Other protocol-defined exclusion criteria may apply