Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study (NCT01237340) | Clinical Trial Compass
TerminatedPhase 3
Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
Stopped: The Sponsor voluntarily terminated this trial because compliance to strict Good Clinical Practice (GCP) requirements was not ensured - No safety concerns
United States59 participantsStarted 2010-10
Plain-language summary
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).
Who can participate
Age range18 Years – 60 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Subject…
What they're measuring
1
Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®