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

February 11, 2016 updated by: Merck KGaA, Darmstadt, Germany

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • 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, France
        • Merck Serono Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

48 hospital pediatric and endocrinology centers or in mixed private and hospital practice will enroll 150 children

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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)
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
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
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
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono S.A.S, France

Investigators

  • Study Chair: Pierre Chatelain, MD, Professor, Service d'Endocrinologie Pédiatrique & Diabétologie Infantile, Hôpital Femme Mère Enfant, Lyon-Bron, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

March 5, 2010

First Submitted That Met QC Criteria

March 5, 2010

First Posted (Estimate)

March 8, 2010

Study Record Updates

Last Update Posted (Estimate)

February 12, 2016

Last Update Submitted That Met QC Criteria

February 11, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • IMP28018

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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