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| Name | Class |
|---|---|
| Merck Serono S.A.S, France | INDUSTRY |
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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.
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:
Secondary objectives:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant somatropin | Drug | as per standard practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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 | 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) | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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48 hospital pediatric and endocrinology centers or in mixed private and hospital practice will enroll 150 children
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| Name | Affiliation | Role |
|---|---|---|
| Pierre Chatelain, MD, Professor | Service d'Endocrinologie Pédiatrique & Diabétologie Infantile, Hôpital Femme Mère Enfant, Lyon-Bron, France | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Merck Serono Investigational Site | Aix-en-Provence | France | ||||
| Merck Serono Investigational Site |
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| Annemasse |
| France |
| Merck Serono Investigational Site | Belfort | France |
| Merck Serono Investigational Site | Besançon | France |
| Merck Serono Investigational Site | Bordeaux | France |
| Merck Serono Investigational Site | Brest | France |
| Merck Serono Investigational Site | Caen | France |
| Merck Serono Investigational Site | Chambéry | France |
| Merck Serono Investigational Site | Clermont-Ferrand | France |
| Merck Serono Investigational Site | Dijon | France |
| Merck Serono Investigational Site | Fréjus | France |
| Merck Serono Investigational Site | Grenoble | France |
| Merck Serono Investigational Site | Hyères | France |
| Merck Serono Investigational Site | La Rochelle | France |
| Merck Serono Investigational Site | Laon | France |
| Merck Serono Investigational Site | Le Havre | France |
| Merck Serono Investigational Site | Le Mans | France |
| Merck Serono Investigational Site | Lille | France |
| Merck Serono Investigational Site | Limoges | France |
| Merck Serono Investigational Site | Lisieux | France |
| Merck Serono Investigational Site | Ludres | France |
| Merck Serono Investigational Site | Lyon-Bron | France |
| Merck Serono Investigational Site | Marseille | France |
| Merck Serono Investigational Site | Mâcon | France |
| Merck Serono Investigational Site | Montbéliard | France |
| Merck Serono Investigational Site | Montluçon | France |
| Merck Serono Investigational Site | Montpellier | France |
| Merck Serono Investigational Site | Nantes | France |
| Merck Serono Investigational Site | Nice | France |
| Merck Serono Investigational Site | Orléans | France |
| Merck Serono Investigational Site | Paris | France |
| Merck Serono Investigational Site | Pringy | France |
| Merck Serono Investigational Site | Puyricard | France |
| Merck Serono Investigational Site | Reims | France |
| Merck Serono Investigational Site | Saint-Priest-en-Jarez | France |
| Merck Serono Investigational Site | Strasbourg | France |
| Merck Serono Investigational Site | Toulon | France |
| Merck Serono Investigational Site | Toulouse | France |
| Merck Serono Investigational Site | Tours | France |
| Merck Serono Investigational Site | Vesoul | France |
| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| D019382 | Human Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
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