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

Stopped early · Phase 3

Conditions studied: Growth Hormone Deficiency (GHD)

In brief

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

Key facts

Study ID

NCT01237340

Run by

EMD Serono

People needed

59

Starts

2010-10-01

Expected to finish

2011-12-01

Last updated by the study team

2013-08-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Study site — US Medical Information, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.