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A Pharmaco-epidemiological Study of Short Patients Born Small for Gestational Age (SGA), Treated With Saizen® (Recombinant Somatropin)

NCT ID: NCT01082354

Last Updated: 2016-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2015-12-31

Brief Summary

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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.

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Detailed Description

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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

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Infant, Small for Gestational Age

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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recombinant somatropin

as per standard practice

Intervention Type DRUG

Other Intervention Names

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Saizen

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Contra-indication in the treatment with Saizen
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Serono S.A.S, France

INDUSTRY

Sponsor Role collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pierre Chatelain, MD, Professor

Role: STUDY_CHAIR

Service d'Endocrinologie Pédiatrique & Diabétologie Infantile, Hôpital Femme Mère Enfant, Lyon-Bron, France

Locations

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Merck Serono Investigational Site

Aix-en-Provence, , France

Site Status

Merck Serono Investigational Site

Annemasse, , France

Site Status

Merck Serono Investigational Site

Belfort, , France

Site Status

Merck Serono Investigational Site

Besançon, , France

Site Status

Merck Serono Investigational Site

Bordeaux, , France

Site Status

Merck Serono Investigational Site

Brest, , France

Site Status

Merck Serono Investigational Site

Caen, , France

Site Status

Merck Serono Investigational Site

Chambéry, , France

Site Status

Merck Serono Investigational Site

Clermont-Ferrand, , France

Site Status

Merck Serono Investigational Site

Dijon, , France

Site Status

Merck Serono Investigational Site

Fréjus, , France

Site Status

Merck Serono Investigational Site

Grenoble, , France

Site Status

Merck Serono Investigational Site

Hyères, , France

Site Status

Merck Serono Investigational Site

La Rochelle, , France

Site Status

Merck Serono Investigational Site

Laon, , France

Site Status

Merck Serono Investigational Site

Le Havre, , France

Site Status

Merck Serono Investigational Site

Le Mans, , France

Site Status

Merck Serono Investigational Site

Lille, , France

Site Status

Merck Serono Investigational Site

Limoges, , France

Site Status

Merck Serono Investigational Site

Lisieux, , France

Site Status

Merck Serono Investigational Site

Ludres, , France

Site Status

Merck Serono Investigational Site

Lyon-Bron, , France

Site Status

Merck Serono Investigational Site

Marseille, , France

Site Status

Merck Serono Investigational Site

Mâcon, , France

Site Status

Merck Serono Investigational Site

Montbéliard, , France

Site Status

Merck Serono Investigational Site

Montluçon, , France

Site Status

Merck Serono Investigational Site

Montpellier, , France

Site Status

Merck Serono Investigational Site

Nantes, , France

Site Status

Merck Serono Investigational Site

Nice, , France

Site Status

Merck Serono Investigational Site

Orléans, , France

Site Status

Merck Serono Investigational Site

Paris, , France

Site Status

Merck Serono Investigational Site

Pringy, , France

Site Status

Merck Serono Investigational Site

Puyricard, , France

Site Status

Merck Serono Investigational Site

Reims, , France

Site Status

Merck Serono Investigational Site

Saint-Priest-en-Jarez, , France

Site Status

Merck Serono Investigational Site

Strasbourg, , France

Site Status

Merck Serono Investigational Site

Toulon, , France

Site Status

Merck Serono Investigational Site

Toulouse, , France

Site Status

Merck Serono Investigational Site

Tours, , France

Site Status

Merck Serono Investigational Site

Vesoul, , France

Site Status

Countries

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France

Other Identifiers

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IMP28018

Identifier Type: -

Identifier Source: org_study_id

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