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

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ClinicalTrials.gov Identifier: NCT01237340
Recruitment Status : Terminated (The Sponsor voluntarily terminated this trial because compliance to strict Good Clinical Practice (GCP) requirements was not ensured - No safety concerns)
First Posted : November 9, 2010
Results First Posted : October 11, 2012
Last Update Posted : August 7, 2013
Sponsor:
Information provided by (Responsible Party):
EMD Serono

November 5, 2010
November 9, 2010
September 11, 2012
October 11, 2012
August 7, 2013
October 2010
December 2011   (Final data collection date for primary outcome measure)
Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen® [ Time Frame: 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.
Laboratory binding antibodies (BAbs+) to Saizen® solution for injection [ Time Frame: 26-weeks ]
The proportion of adult subjects with GHD who develop binding antibodies (BAbs+) to Saizen® solution for injection at any time during a 26-week (6-month) course of single daily SC injections.
Complete list of historical versions of study NCT01237340 on ClinicalTrials.gov Archive Site
  • Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen® [ Time Frame: 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 [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 ]
  • 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 ]
    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 [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26 ]
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: 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).
Laboratory neutralizing antibodies (NAbs+) to Saizen® solution for injection [ Time Frame: week 26 ]
Number of subjects with a confirmatory positive binding antibody test and a positive neutralizing antibody test at any time during the study divided by the total number of subjects who receive study drug and have follow-up BAbs data
Not Provided
Not Provided
 
Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
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).
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Growth Hormone Deficiency (GHD)
Drug: Saizen®
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:
  • r-hGH
  • Somatropin
Experimental: Saizen®
Intervention: Drug: Saizen®
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
59
50
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 60 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01237340
EMR 701048-009
No
Not Provided
Not Provided
EMD Serono
EMD Serono
Not Provided
Study Director: Medical Responsible Merck Serono S.A., Geneva
EMD Serono
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP