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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT01237340
• Date of registration: 05/11/2010
• Prospective Registration: No
• Primary sponsor: EMD Serono
• Public title: Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
• Scientific 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)
• Date of first enrolment: October 2010
• Target sample size: 59
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT01237340
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Medical Responsible
• Affiliation: Merck Serono S.A., Geneva

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 60 Years
Gender: All

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency (GHD)

Intervention(s)

Drug: Saizen®

Primary Outcome(s)

Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen® [Time Frame: Baseline up to Week 26]

Secondary Outcome(s)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time Frame: Day 1 up to 28 days after last dose of study treatment]

Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen® [Time Frame: Baseline up to Week 26]

Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS) [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26]

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]

Insulin-like Growth Factor-I (IGF-1) Levels [Time Frame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26]

Secondary ID(s)

EMR 701048-009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/10/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01237340