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

Phase 3

Terminated

• Conditions: Growth Hormone Deficiency (GHD)
• Interventions: Drug: Saizen®

• Registration Number: NCT01237340
• Lead Sponsor: EMD Serono

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-08
• Study First Posted: 2010-11-09
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Results First Submitted: 2012-09-11
• Results First Submitted QC: 2012-09-11
• Results First Posted: 2012-10-11
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-04
• Last Update Posted: 2013-08-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 59

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Saizen®	Saizen®	-

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®	Baseline up to Week 26	Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency.
Insulin-like Growth Factor-I (IGF-1) Levels	Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)	Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26	Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1.
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels	Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	Day 1 up to 28 days after last dose of study treatment	Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks \[28 days\] after the final administration of Saizen® solution for injection).