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

Infant, Small for Gestational Age Clinical Trial

— SEPAGE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01082354
• Other study ID #: IMP28018
• Status: Completed
• Phase: N/A
• First received: March 5, 2010
• Last updated: February 11, 2016
• Start date: March 2009
• Est. completion date: December 2015

Study information

• Verified date: February 2016
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Haute Autorité de Santé Transparency Commission
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Infant, Small for Gestational Age

Intervention

Drug:
• recombinant somatropin
as per standard practice

Locations

Country	Name	City	State
France	Merck Serono Investigational Site	Aix en Provence
France	Merck Serono Investigational Site	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	Chambery
France	Merck Serono Investigational Site	Clermont-Ferrand
France	Merck Serono Investigational Site	Dijon
France	Merck Serono Investigational Site	Frejus
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	Macon
France	Merck Serono Investigational Site	Marseille
France	Merck Serono Investigational Site	Montbeliard
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

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono S.A.S, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Primary	Biochemical and endocrinological parameters	Tolerance; Concomitant treatments	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	No