Infant, Small for Gestational AgeSEPAGENCT01082354
A Pharmaco-epidemiological Study of Short Patients Born Small for Gestational Age (SGA), Treated With Saizen® (Recombinant Somatropin)
An observational study of Infant, Small for Gestational Age, run by Merck KGaA, Darmstadt, Germany at 40 sites in France.
Trial summary
This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with Saizen. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Small for Gestational Age
- What is being tested?
- recombinant somatropin
- How many people
- 150 participants
- Where
- 40 sitesFrance
- Study dates
- Mar 2009to Dec 2015
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 48 hospital pediatric and endocrinology centers or in mixed private and hospital practice will enroll 150 children
Who may be able to join
- Short children born SGA requiring treatment with Saizen, new to growth hormone treatment or being treated with growth hormones for less than 12 months of inclusion
- Subjects whose parents have given their written consent for participation in this study
Who cannot join
- Contra-indication in the treatment with Saizen
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
France40 sites
Merck Serono Investigational Site
Aix-en-Provence
Merck Serono Investigational Site
Annemasse
Merck Serono Investigational Site
Belfort
Merck Serono Investigational Site
Besançon
Merck Serono Investigational Site
Bordeaux
Merck Serono Investigational Site
Brest
Merck Serono Investigational Site
Caen
Merck Serono Investigational Site
Chambéry
Merck Serono Investigational Site
Clermont-Ferrand
Merck Serono Investigational Site
Dijon
Merck Serono Investigational Site
Fréjus
Merck Serono Investigational Site
Grenoble
Merck Serono Investigational Site
Hyères
Merck Serono Investigational Site
La Rochelle
Merck Serono Investigational Site
Laon
Merck Serono Investigational Site
Le Havre
Merck Serono Investigational Site
Le Mans
Merck Serono Investigational Site
Lille
Merck Serono Investigational Site
Limoges
Merck Serono Investigational Site
Lisieux
Merck Serono Investigational Site
Ludres
Merck Serono Investigational Site
Lyon-Bron
Merck Serono Investigational Site
Mâcon
Merck Serono Investigational Site
Marseille
Merck Serono Investigational Site
Montbéliard
Merck Serono Investigational Site
Montluçon
Merck Serono Investigational Site
Montpellier
Merck Serono Investigational Site
Nantes
Merck Serono Investigational Site
Nice
Merck Serono Investigational Site
Orléans
Merck Serono Investigational Site
Paris
Merck Serono Investigational Site
Pringy
Merck Serono Investigational Site
Puyricard
Merck Serono Investigational Site
Reims
Merck Serono Investigational Site
Saint-Priest-en-Jarez
Merck Serono Investigational Site
Strasbourg
Merck Serono Investigational Site
Toulon
Merck Serono Investigational Site
Toulouse
Merck Serono Investigational Site
Tours
Merck Serono Investigational Site
Vesoul
About this study
Official title: Non Interventional Study on the Follow-up, by Specialists, of Short Children Born Small for Gestational Age and Treated With SAIZEN®- SEPAGE Study
This one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with Saizen.
Read the detailed description
The term "small for gestational age" (SGA) is a pathological medical condition known since about two decades supported by two consensus conferences of 2001. It inhibits the height and/or weight of the child at birth without prejudging the mechanisms that alter these. This study will be carried out by hospital pediatricians, endocrinologists or physicians in private, mixed private and hospital practice in metropolitan France. Subjects will be monitored by doctors in accordance with the normal scope of follow-up of pathology until their final growth and until they reach adult height and/or until the treatment is discontinued. The participating doctors will include all the short SGA subjects coming for consultation or the follow-up (for less than 12 months) of their treatment by Saizen in this study. The inclusions will take place over a period of 21 months.
OBJECTIVES
Primary objective:
- To describe the characteristics of short children born SGA (SGA subjects) treated with Saizen
Secondary objectives:
- To describe the terms and conditions for the prescription of Saizen in terms of dosage, duration of treatment, reason for discontinuation and compliance
- To describe the effects of Saizen on growth and final height
- To describe the tolerance of Saizen. For each subject and during each visit, the participating doctor will complete an electronic data collection form.
- Conditions
- Infant, Small for Gestational Age
- Being tested
- recombinant somatropin
- Keywords
- Infant, Low birth weight, Infant, Low birth height, Infant, Small for Gestational Age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant somatropinDrug
Also called Saizen
as per standard practice
What is being measured
The primary outcome is the main question the study is designed to answer.
Auxological characteristics (height and weight, head circumference, growth curve used, bone age) and Clinical examination (cardiac frequency, systolic blood pressure, diastolic blood pressure, Tanner pubertal stage)
Measured: Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
Saizen prescription and compliance to treatment
Measured: Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
Temporary discontinuation of treatment with Saizen if > 1 week (number, duration, person responsible for the discontinuation, reason, dose upon resumption of treatment) and final discontinuation of treatment with Saizen (date and reason)
Measured: Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
Biochemical and endocrinological parameters
- Tolerance
- Concomitant treatments
Measured: Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2010 (estimated)
- Study startMar 2009
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, Small for Gestational AgeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck KGaA, Darmstadt, Germany
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.A.S, France
- Responsible party
- Sponsor
- Investigators
- Pierre Chatelain, MD, Professor, Study chair, Service d'Endocrinologie Pédiatrique & Diabétologie Infantile, Hôpital Femme Mère Enfant, Lyon-Bron, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01082354
- Sponsor's protocol ID
- IMP28018
- Acronym
- SEPAGE
- Status last verified
- Feb 2016
- First submitted
- 5 Mar 2010
- Last updated
- 12 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Interventional Study on the Follow-up, by Specialists, of Short Children Born Small for Gestational Age and Treated With SAIZEN®- SEPAGE Study
- ClinicalTrials.gov ID
- NCT01082354
- Acronym / sponsor ID
- SEPAGE / IMP28018
- Conditions
- Infant, Small for Gestational Age
- Keywords
- Infant, Low birth weight, Infant, Low birth height, Infant, Small for Gestational Age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Merck KGaA, Darmstadt, GermanyIndustry (pharma, biotech, devices)
- Collaborators
- Merck Serono S.A.S, France
- Study start
- Mar 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 8 Mar 2010 (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 one-arm, multi-centric, non-randomized, observational, open label, prospective study was designed to study short subjects born SGA, by pediatricians, endocrinologists or physicians in private, mixed private and hospital practice treated with Saizen.
Detailed description
The term "small for gestational age" (SGA) is a pathological medical condition known since about two decades supported by two consensus conferences of 2001. It inhibits the height and/or weight of the child at birth without prejudging the mechanisms that alter these. This study will be carried out by hospital pediatricians, endocrinologists or physicians in private, mixed private and hospital practice in metropolitan France. Subjects will be monitored by doctors in accordance with the normal scope of follow-up of pathology until their final growth and until they reach adult height and/or until the treatment is discontinued. The participating doctors will include all the short SGA subjects coming for consultation or the follow-up (for less than 12 months) of their treatment by Saizen in this study. The inclusions will take place over a period of 21 months.
OBJECTIVES
Primary objective:
- To describe the characteristics of short children born SGA (SGA subjects) treated with Saizen
Secondary objectives:
- To describe the terms and conditions for the prescription of Saizen in terms of dosage, duration of treatment, reason for discontinuation and compliance
- To describe the effects of Saizen on growth and final height
- To describe the tolerance of Saizen. For each subject and during each visit, the participating doctor will complete an electronic data collection form.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 48 hospital pediatric and endocrinology centers or in mixed private and hospital practice will enroll 150 children
Key inclusion criteria (2 listed)
- Short children born SGA requiring treatment with Saizen, new to growth hormone treatment or being treated with growth hormones for less than 12 months of inclusion
- Subjects whose parents have given their written consent for participation in this study
Key exclusion criteria (1 listed)
- Contra-indication in the treatment with Saizen
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 |
|---|---|---|
| recombinant somatropinAlso: Saizenas per standard practice | Drug | – |
Primary outcome
Auxological characteristics (height and weight, head circumference, growth curve used, bone age) and Clinical examination (cardiac frequency, systolic blood pressure, diastolic blood pressure, Tanner pubertal stage)
Time frame: Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
Saizen prescription and compliance to treatment
Time frame: Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
Temporary discontinuation of treatment with Saizen if > 1 week (number, duration, person responsible for the discontinuation, reason, dose upon resumption of treatment) and final discontinuation of treatment with Saizen (date and reason)
Time frame: Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
Biochemical and endocrinological parameters
Time frame: Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment
* Tolerance * Concomitant treatments
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 12 Feb 2016.
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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.
Pierre Chatelain, MD, Professor study chair
Service d'Endocrinologie Pédiatrique & Diabétologie Infantile, Hôpital Femme Mère Enfant, Lyon-Bron, France
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Small for Gestational Age, run by Merck KGaA, Darmstadt, Germany at 40 sites in France.
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 2 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 12 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in France. 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.
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?
Auxological characteristics (height and weight, head circumference, growth curve used, bone age) and Clinical examination (cardiac frequency, systolic blood pressure, diastolic blood pressure, Tanner pubertal stage) (time frame: Inclusion visit to follow-up visits at 3, 6 and 12 month and annual until the adult height is reached and or the final discontinuation of the treatment). The study lists 4 primary outcomes in all. 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 12 Feb 2016.