- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01237340
Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
August 4, 2013 updated by: EMD Serono
A Phase IIIb, Open-label, Single-arm, Multicenter Study to Assess the Immunogenicity of the Recombinant-Human Growth Hormone (r-hGH) Liquid Multidose Formulation (Saizen® Solution for Injection) When Administered to Male and Female Adults With Documented Growth Hormone Deficiency (GHD)
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).
Study Overview
Study Type
Interventional
Enrollment (Actual)
59
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Massachusetts
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US Medical Information, Massachusetts, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Saizen®
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®
Time Frame: Baseline up to Week 26
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Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.
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Baseline up to Week 26
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®
Time Frame: Baseline up to Week 26
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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.
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Baseline up to Week 26
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Insulin-like Growth Factor-I (IGF-1) Levels
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
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Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
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Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
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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.
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Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
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Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
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Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
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Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time Frame: Day 1 up to 28 days after last dose of study treatment
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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).
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Day 1 up to 28 days after last dose of study treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Medical Responsible, Merck Serono S.A., Geneva
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
November 5, 2010
First Submitted That Met QC Criteria
November 8, 2010
First Posted (Estimate)
November 9, 2010
Study Record Updates
Last Update Posted (Estimate)
August 7, 2013
Last Update Submitted That Met QC Criteria
August 4, 2013
Last Verified
August 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMR 701048-009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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