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

NCT01237340 | Terminated Phase 3 Results

• 1 other identifier: EMR 701048-009
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Growth Hormone Deficiency (GHD)

Keywords

Adult Growth Hormone Deficiency (AGHD); immunogenicity; growth hormone; antibodies; GH biomarkers; IGF-I

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®

  Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.

  Baseline up to Week 26

Secondary Outcomes (5)

• Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®

  Baseline up to Week 26

• 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 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

Study Arms (1)

Saizen®

EXPERIMENTAL

Drug: Saizen®

Interventions

Saizen® DRUG

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.

Also known as: r-hGH, Somatropin

Saizen®

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• EMD Serono: lead

Study Sites (1)

Unknown Facility

US Medical Information, Massachusetts, United States

Location

MeSH Terms

Conditions

Dwarfism, Pituitary

Interventions

Human Growth Hormone

Condition Hierarchy (Ancestors)

Dwarfism; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Bone Diseases, Endocrine; Hypopituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Growth Hormone; Pituitary Hormones, Anterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Merck KGaA Communication Center
• Organization: Merck Serono, a division of Merck KGaA

service@merckgroup.com

+49-6151-72-5200

Study Officials

• Medical Responsible

  Merck Serono S.A., Geneva

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2010
• First Posted: November 9, 2010
• Study Start: October 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: August 7, 2013
• Results First Posted: October 11, 2012

Record last verified: 2013-08

Locations

US (1)