Idiopathic Growth Hormone DeficiencyPhase 3NCT02173821
A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Study (FE 999905 CS07) of Zomacton in Children With Growth Hormone Deficiency
A Phase 3 study testing Blood sampling in people with Idiopathic Growth Hormone Deficiency, run by Ferring Pharmaceuticals at 7 sites in 7 countries.
Trial summary
This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Idiopathic Growth Hormone Deficiency
- What is being tested?
- Blood sampling
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 7 sitesin 7 countries
- Study dates
- Oct 2014to Apr 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Previous participation in trial FE 999905 CS07 and presence of anti-hGH antibodies at any post-dosing visit throughout the 12-month treatment period
- Signed informed consent and obtained assent according to local rules and practice
- Information on medical history, concomitant medications, and growth hormone therapy since completion of trial FE 999905 CS07
Who cannot join
- There are no pre-defined exclusion criteria in this study
Trial locations and contacts
7 sites in 7 countries.
7 sites in 7 countries
Hungary1 site
Szent János Kórház és Észak Budai Egyesített Kórházai (there may be other sites in this country)
Budapest
India1 site
Seth GSMC & KEM Hospital (there may be other sites in this country)
Maharashtra
Israel1 site
The Chaim Sheba Medical Center (there may be other sites in this country)
Ramat Gan
Poland1 site
Uniwersyteckie Centrum Kliniczne (there may be other sites in this country)
Gdansk
Romania1 site
Paediatric Endocrinology/Medicali's SRL (there may be other sites in this country)
Timișoara
Russia1 site
Federal State Institution "Endocrinology Scientific Center of Rosmedtechnology" (there may be other sites in this country)
Moscow
Ukraine1 site
Institute of Endocrinology and Metabolism named after Komisarenko of AMS Ukraine (there may be other sites in this country)
Kiev
About this study
Official title: A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Randomised, Open-label, Parallel-group, Multi-centre Trial (FE 999905 CS07) in Which the Efficacy and Safety of 12 Months' Treatment With One Daily Dose of ZOMACTON Were Compared to One Daily Dose of GENOTROPIN
This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No investigational medicinal product will be administered in connection with this follow-up study. Eligible patients will attend one visit in this follow-up study.
- Conditions
- Idiopathic Growth Hormone Deficiency
- Being tested
- Blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingProcedure or surgery
Blood sample will be collected at a single visit
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of anti-human Growth Hormone (hGH) antibodies
Measured as percentage of patients with positive anti-hGH antibodies.
Measured: At visit 1
Secondary outcomes (2)
Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples
Measured as percentage of patients with neutralising antibodies in patients with confirmed positive anti-hGH antibody samples.
Measured: At visit 1
Binding capacity levels in confirmed anti-hGH antibody positive samples
Measured as percentage of patients with binding capacity <2 mg/L in patients with confirmed positive anti-hGH antibody samples.
Measured: At visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Growth Hormone DeficiencyStudies 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
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ferring Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Development Support, Study director, Ferring Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02173821
- Sponsor's protocol ID
- 000134
- Other IDs
- 2014-000627-24, 2014
- Status last verified
- May 2015
- First submitted
- 23 Jun 2014
- Last updated
- 5 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Follow-up Study to Examine the Presence of Anti-human Growth Hormone Antibodies Following a Randomised, Open-label, Parallel-group, Multi-centre Trial (FE 999905 CS07) in Which the Efficacy and Safety of 12 Months' Treatment With One Daily Dose of ZOMACTON Were Compared to One Daily Dose of GENOTROPIN
- ClinicalTrials.gov ID
- NCT02173821
- Acronym / sponsor ID
- 000134
- Conditions
- Idiopathic Growth Hormone Deficiency
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ferring PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 25 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a follow-up study of patients, treated with one daily dose of Zomacton or one daily dose of Genotropin in the previously completed FE 999905 CS07 trial, who had presence of anti-hGH antibodies at any post-dosing visit during the 12-month treatment period. No investigational medicinal product will be administered in connection with this follow-up study. Eligible patients will attend one visit in this follow-up study.
Study design
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Previous participation in trial FE 999905 CS07 and presence of anti-hGH antibodies at any post-dosing visit throughout the 12-month treatment period
- Signed informed consent and obtained assent according to local rules and practice
- Information on medical history, concomitant medications, and growth hormone therapy since completion of trial FE 999905 CS07
Key exclusion criteria (1 listed)
- There are no pre-defined exclusion criteria in this study
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 |
|---|---|---|
| Blood samplingBlood sample will be collected at a single visit | Procedure or surgery | – |
Primary outcome
Prevalence of anti-human Growth Hormone (hGH) antibodies
Time frame: At visit 1
Measured as percentage of patients with positive anti-hGH antibodies.
2 secondary outcomes
Prevalence of neutralising antibodies in confirmed positive anti-hGH antibody samples
Time frame: At visit 1
Binding capacity levels in confirmed anti-hGH antibody positive samples
Time frame: At visit 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2015.
Related trials for Idiopathic Growth Hormone Deficiency
RecruitingPhase 3
Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
Turner Syndrome, Short Stature Homeobox Gene Mutation
RecruitingObservational study
Long-term Safety and Effectiveness of Growtropin®-II Treatment in Children With Short Stature
Growth Hormone Deficiency, Idiopathic Short Stature
Enrolling by invitationPhase 2
A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211)
Growth Hormone Deficiency
Active, not recruitingPhase 2
PK and PD Study of LUM-201 in Children With Idiopathic Growth Hormone Deficiency: (OraGrowtH212)
Growth Hormone Deficiency
RecruitingObservational study
Long-term Safety and Effectiveness of Growth Hormone With GHD, TS, CRF, SGA , ISS and PWS in Children
Growth Hormone Deficiency, Turner Syndrome
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.
Clinical Development Support study director
Ferring Pharmaceuticals
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Blood sampling in people with Idiopathic Growth Hormone Deficiency, run by Ferring Pharmaceuticals at 7 sites in 7 countries.
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 3 inclusion and 1 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: finished, as of the sponsor's last update on 5 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Hungary, India, Israel, Poland, Romania and 2 more countries. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Prevalence of anti-human Growth Hormone (hGH) antibodies (time frame: At visit 1). 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 5 May 2015.