Growth Hormone Deficiency (GHD)Phase 3NCT01237340
Saizen® Solution for Injection Adult Growth Hormone Deficiency (GHD) Immunogenicity Study
A Phase 3 study testing Saizen® in people with Growth Hormone Deficiency (GHD), run by EMD Serono at 1 site in United States.
Trial summary
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Growth Hormone Deficiency (GHD)
- What is being tested?
- Saizen®
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Dec 2011
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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)
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this 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)
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).
- Conditions
- Growth Hormone Deficiency (GHD)
- Being tested
- Saizen®
- Keywords
- Adult Growth Hormone Deficiency (AGHD), immunogenicity, growth hormone, antibodies, GH biomarkers, IGF-I
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saizen®Drug
Also called r-hGH, Somatropin
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.
| Study group | Role | What they receive |
|---|---|---|
| Saizen® | Experimental | Not described Receives: Drug: Saizen® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to Week 26
Secondary outcomes (5)
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.
Measured: Baseline up to Week 26
Insulin-like Growth Factor-I (IGF-1) Levels
Measured: 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.
Measured: Baseline, Week 2, Week 4, Week 8, Week 13, Week 18, Week 26
Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) Levels
Measured: 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).
Measured: Day 1 up to 28 days after last dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2011
- Study completionDec 2011
Why it stopped: The Sponsor voluntarily terminated this trial because compliance to strict Good Clinical Practice (GCP) requirements was not ensured - No safety concerns
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Growth Hormone Deficiency (GHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- EMD Serono
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Responsible, Study director, Merck Serono S.A., Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237340
- Sponsor's protocol ID
- EMR 701048-009
- Status last verified
- Aug 2013
- First submitted
- 5 Nov 2010
- Last updated
- 7 Aug 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01237340
- Acronym / sponsor ID
- EMR 701048-009
- Conditions
- Growth Hormone Deficiency (GHD)
- Keywords
- Adult Growth Hormone Deficiency (AGHD), immunogenicity, growth hormone, antibodies, GH biomarkers, IGF-I
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The Sponsor voluntarily terminated this trial because compliance to strict Good Clinical Practice (GCP) requirements was not ensured - No safety concerns
- Enrolment
- 59 participants (actual)
- Lead sponsor
- EMD SeronoIndustry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Posted 11 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the immunogenicity of Saizen® solution for injection in adult subjects with documented Growth Hormone Deficiency (GHD).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Saizen® | Experimental | Drug: Saizen® |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saizen®Also: r-hGH, SomatropinSingle 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. | Drug | Saizen® |
Primary outcome
Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen®
Time frame: Baseline up to Week 26
Binding antibodies (BAbs) are all antibodies which are capable of binding to the investigational drug molecule (Saizen®), irrespective of their binding site.
5 secondary outcomes
Number of Participants Who Developed Positive Neutralizing Antibodies (NAbs+) to Saizen®
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)
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)
Time frame: Day 1 up to 28 days after last dose of study treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Randomized Clinical Trial of Two Different Initial Growth Hormone Doses in Children
Growth Disorders, Growth Failure
RecruitingPhase 3
Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency
Growth Hormone Deficiency (GHD)
RecruitingPhase 3
Growth Hormone Replacement Therapy in Veterans With Mild Traumatic Brain Injury (mTBI) and Adult Growth Hormone Deficiency (AGHD)
Adult Growth Hormone Deficiency, Mild Traumatic Brain Injury
Enrolling by invitationObservational study
Influence of Adherence to Growth Hormone Therapy (GHT) With Norditropin® on Near Final Height in Patients With Growth Hormone Deficiency (GHD) and Born Small for Gestational Age (SGA)
Growth Hormone Deficiency in Children, Born Small for Gestational Age
Active, not recruitingObservational study
Ngenla Subcutaneous Injection Special Investigation
Growth Hormone Deficiency Without Epiphyseal Closure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Responsible study director
Merck Serono S.A., Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Saizen® in people with Growth Hormone Deficiency (GHD), run by EMD Serono at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Developed Positive Binding Antibodies (BAbs+) to Saizen® (time frame: Baseline up to Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.