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

This study has been terminated.
(The Sponsor voluntarily terminated this trial because compliance to strict Good Clinical Practice (GCP) requirements was not ensured - No safety concerns)
Sponsor:
Information provided by (Responsible Party):
EMD Serono
ClinicalTrials.gov Identifier:
NCT01237340
First received: November 5, 2010
Last updated: August 4, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Growth Hormone Deficiency (GHD)
Drug: Saizen®
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by EMD Serono:

Primary Outcome Measures:
  • Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen® [ Time Frame: Baseline up to Week 26 ] [ Designated as safety issue: No ]
    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:
  • Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen® [ Time Frame: Baseline up to Week 26 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
  • Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 up to 28 days after last dose of study treatment ] [ Designated as safety issue: Yes ]
    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).


Enrollment: 59
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saizen® 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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237340

Locations
United States, Massachusetts
US Medical Information, Massachusetts, United States
Sponsors and Collaborators
EMD Serono
Investigators
Study Director: Medical Responsible Merck Serono S.A., Geneva
  More Information

No publications provided

Responsible Party: EMD Serono
ClinicalTrials.gov Identifier: NCT01237340     History of Changes
Other Study ID Numbers: EMR 701048-009
Study First Received: November 5, 2010
Results First Received: September 11, 2012
Last Updated: August 4, 2013
Health Authority: United States: Food and Drug Administration
United States: Federal Government
United States: Institutional Review Board
Hungary: National Institute of Pharmacy
Czech Republic: State Institute for Drug Control
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by EMD Serono:
Adult Growth Hormone Deficiency (AGHD)
immunogenicity
growth hormone
antibodies
GH biomarkers
IGF-I

Additional relevant MeSH terms:
Dwarfism, Pituitary
Endocrine System Diseases
Bone Diseases
Bone Diseases, Developmental
Bone Diseases, Endocrine
Brain Diseases
Central Nervous System Diseases
Dwarfism
Hypopituitarism
Hypothalamic Diseases
Musculoskeletal Diseases
Nervous System Diseases
Pituitary Diseases
Hormones
Pharmaceutical Solutions
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014