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

NCT ID: NCT01237340

Last Updated: 2013-08-07

Basic Information

• 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

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

Conditions

Growth Hormone Deficiency (GHD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

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

r-hGH; Somatropin

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

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

EMD Serono

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Responsible

Role: STUDY_DIRECTOR

Merck Serono S.A., Geneva

Locations

US Medical Information, Massachusetts, United States

Countries

United States

Other Identifiers

EMR 701048-009

Identifier Type: -

Identifier Source: org_study_id