Clinical trial NCT01237340: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Growth Hormone Deficiency (GHD)
Keywords: Adult Growth Hormone Deficiency (AGHD)
immunogenicity
growth hormone
antibodies
GH biomarkers
IGF-I
Lead sponsor: EMD Serono
Sponsor class: INDUSTRY
First posted: 2010-11-09
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®
timeFrame: Baseline up to Week 26
Secondary outcomes:
measure: Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®
timeFrame: Baseline up to Week 26
measure: Insulin-like Growth Factor-I (IGF-1) Levels
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
measure: Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
measure: Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
timeFrame: Day 1 up to 28 days after last dose of study treatment
Other outcomes:
Locations:
city: US Medical Information
country: United States
state: Massachusetts
Study officials:
affiliation: Merck Serono S.A., Geneva
name: Medical Responsible
role: STUDY_DIRECTOR
References: