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

NCT ID: NCT01237340

Last Updated: 2013-08-07

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-12-31

Brief Summary

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

Detailed Description

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Conditions

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Growth Hormone Deficiency (GHD)

Keywords

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Saizen®

Group Type EXPERIMENTAL

Saizen®

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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r-hGH Somatropin

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMD Serono

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Responsible

Role: STUDY_DIRECTOR

Merck Serono S.A., Geneva

Locations

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US Medical Information, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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EMR 701048-009

Identifier Type: -

Identifier Source: org_study_id