TerminatedNCT01237340Updated Aug 7, 2013Results posted

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

A Phase 3 interventional study of Saizen® in Growth Hormone Deficiency (GHD), sponsored by EMD Serono. Terminated at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2013-08-07.

Sponsored by EMD Serono · Phase 3, Interventional, and Treatment

Why this study was terminated

The Sponsor voluntarily terminated this trial because compliance to strict Good Clinical Practice (GCP) requirements was not ensured - No safety concerns

Phase: Phase 3
Study type: Interventional
Enrollment: 59
Allocation: Not applicable
Ages: 18 Years to 60 Years
Sex: All

Study summary

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

Conditions studied

Growth Hormone Deficiency (GHD)

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Keywords

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

In context

Dwarfism, Pituitary

164 studies on the registry are indexed under Dwarfism, Pituitary; 25 are open to participants now.

This study's enrollment of 59 is below the median of 72 across 122 interventional studies indexed under Dwarfism, Pituitary.

Browse Dwarfism, Pituitary studies →

Lead sponsor

EMD Serono is the lead sponsor of 88 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 60 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 59 participants (actual)

Study arms

Experimental
Saizen®
Drug: Saizen®

Interventions

DrugSaizen®
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.
Also known as: r-hGH, Somatropin

What researchers measure

Primary outcomes

Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®
Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.
Time frame: Baseline up to Week 26

Secondary outcomes

Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®
Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency.
Time frame: Baseline up to 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
Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)
Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1.
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
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks \[28 days\] after the final administration of Saizen® solution for injection).
Time frame: Day 1 up to 28 days after last dose of study treatment

Results

Posted Oct 11, 2012

Participant flow

Participant flow — Overall Study
Milestone	Saizen®
Started	59
Completed	19
Not completed	40
Withdrew: Adverse event	3
Withdrew: Withdrawal by subject	1
Withdrew: Early termination of the trial	36

Outcome measures

PrimaryNumber of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®

Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.

Time frame:: Baseline up to Week 26
Reported as:: Number · participants

Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®
participants	Saizen®
Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®	1

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

Neutralizing antibodies (NAbs) are defined as a subgroup of BAbs which bind to the active sites of the investigational drug molecule (Saizen®) and therefore neutralize its potency.

Time frame:: Baseline up to Week 26
Reported as:: Number · participants

Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®
participants	Saizen®
Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®	0

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

Time frame:: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
Reported as:: Mean · nanomole per liter (nmol/L)

Insulin-like Growth Factor-I (IGF-1) Levels
nanomole per liter (nmol/L)	GH Treatment-Naive	GH Treatment-Experienced
Baseline (n = 49, 8)	11.492 ± 6.694	20.225 ± 10.194
Week 2 (n = 47, 8)	18.923 ± 10.394	28.663 ± 9.001
Week 4 (n = 49, 8)	19.914 ± 11.532	24.500 ± 11.176
Week 8 (n = 49, 8)	21.155 ± 10.520	27.075 ± 6.815
Week 13 (n = 46, 8)	23.415 ± 8.020	26.413 ± 8.767
Week 18 (n = 31, 4)	24.948 ± 9.300	25.650 ± 8.502
Week 26 (n = 48, 8)	24.117 ± 11.085	27.438 ± 12.402

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

Insulin-like Growth Factor-1 Standard Deviation Score (IGF-1 SDS) was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1.

Time frame:: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
Reported as:: Mean · standard deviation score

Insulin-like Growth Factor-I Standard Deviation Score (IGF-1 SDS)
standard deviation score	GH Treatment-Naive	GH Treatment-Experienced
Baseline (n = 49, 8)	-2.914 ± 2.268	-0.550 ± 2.274
Week 2 (n = 47, 8)	-0.926 ± 2.300	0.951 ± 1.411
Week 4 (n = 49, 8)	-0.867 ± 2.615	0.153 ± 1.762
Week 8 (n = 49, 8)	-0.464 ± 2.274	0.834 ± 1.063
Week 13 (n = 46, 8)	0.212 ± 1.832	0.666 ± 1.225
Week 18 (n = 31, 4)	0.455 ± 1.816	1.043 ± 1.144
Week 26 (n = 48, 8)	0.167 ± 2.016	0.544 ± 1.894

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

Time frame:: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
Reported as:: Mean · nmol/L

Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels
nmol/L	GH Treatment-Naive	GH Treatment-Experienced
Baseline (n = 51, 8)	124.941 ± 31.899	133.375 ± 36.024
Week 2 (n = 49, 8)	137.408 ± 35.088	162.125 ± 35.203
Week 4 (n = 49, 8)	144.592 ± 32.632	147.750 ± 26.451
Week 8 (n = 50, 8)	147.460 ± 36.381	156.625 ± 36.190
Week 13 (n = 47, 8)	149.404 ± 28.272	151.875 ± 35.679
Week 18 (n = 32, 4)	148.813 ± 39.754	155.500 ± 36.235
Week 26 (n = 49, 8)	152.429 ± 35.649	147.500 ± 30.402

SecondaryNumber of Participants With Treatment Emergent Adverse Events (TEAEs)

Adverse events (AEs): Any untoward medical occurrence in the form of signs, clinically significant abnormalities in laboratory findings, diseases, symptoms, or worsening of complications. TEAEs: AEs occurring after the first administration of Saizen® solution for injection (on Day 1) up to the scheduled routine post treatment follow-up visit (4 weeks \[28 days\] after the final administration of Saizen® solution for injection).

Time frame:: Day 1 up to 28 days after last dose of study treatment
Reported as:: Number · participants

Number of Participants With Treatment Emergent Adverse Events (TEAEs)
participants	Saizen®
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	40

Adverse events

Collected over Day 1 up to 28 days after last dose of study treatment. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Saizen®	—	3/59 (5.1%)	13/59 (22%)

Most frequent serious events

Most frequent serious events
Event	Saizen®
AnxietyPsychiatric disorders	1/59
DepressionPsychiatric disorders	1/59
Hepatic enzyme increasedInvestigations	1/59
HyponatraemiaMetabolism and nutrition disorders	1/59

Most frequent other events

Most frequent other events
Event	Saizen®
Oedema peripheralGeneral disorders	5/59
NasopharyngitisInfections and infestations	4/59
HeadacheNervous system disorders	3/59
Insulin-like growth factor increasedInvestigations	3/59
CoughRespiratory, thoracic and mediastinal disorders	3/59

Baseline characteristics

Age Continuous
Age Continuous(years)	Saizen®
Mean	44.7 ± 10.3

Sex: Female, Male
Sex: Female, Male(Participants)	Saizen®
Female	30
Male	29

Study locations

1 site

US Medical Information, Massachusetts, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 7, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01237340
Lead sponsor: EMD Serono
Responsible party: Sponsor
First posted: Nov 9, 2010
Start date: Oct 2010
Primary completion: Dec 2011
Completion: Dec 2011
Results posted: Oct 11, 2012
Last update: Aug 7, 2013

Study contacts

Medical Responsible

study director · Merck Serono S.A., Geneva

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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