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

Information source: EMD Serono
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Growth Hormone Deficiency (GHD)

Intervention: Saizen® (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: EMD Serono

Official(s) and/or principal investigator(s):
Medical Responsible, Study Director, Affiliation: Merck Serono S.A., Geneva

Summary

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

Clinical Details

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 design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

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

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

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

Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels

Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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

Locations and Contacts

US Medical Information, Massachusetts, United States
Additional Information

Starting date: October 2010
Last updated: August 4, 2013

Page last updated: August 23, 2015

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