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

Primary Purpose

Growth Hormone Deficiency (GHD)

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

Saizen®

About this trial

This is an interventional treatment trial for Growth Hormone Deficiency (GHD) focused on measuring Adult Growth Hormone Deficiency (AGHD), immunogenicity, growth hormone, antibodies, GH biomarkers, IGF-I

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Saizen®

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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

Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)

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

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

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).

Full Information

NCT ID

NCT01237340

First Posted

November 5, 2010

Last Updated

August 4, 2013

Sponsor

EMD Serono

1. Study Identification

Unique Protocol Identification Number

NCT01237340

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2013

Overall Recruitment Status

Terminated

Why Stopped

The Sponsor voluntarily terminated this trial because compliance to strict Good Clinical Practice (GCP) requirements was not ensured - No safety concerns

Study Start Date

October 2010 (undefined)

Primary Completion Date

December 2011 (Actual)

Study Completion Date

December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

EMD Serono

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Growth Hormone Deficiency (GHD)

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Saizen®

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Saizen®

Other Intervention Name(s)

r-hGH, Somatropin

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Description

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

Time Frame

Baseline up to Week 26

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Baseline up to Week 26

Title

Insulin-like Growth Factor-I (IGF-1) Levels

Time Frame

Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26

Title

Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)

Description

Time Frame

Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26

Title

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

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Description

Time Frame

Day 1 up to 28 days after last dose of study treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Responsible

Organizational Affiliation

Merck Serono S.A., Geneva

Official's Role

Study Director

Facility Information:

City

US Medical Information

State/Province

Massachusetts

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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