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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Merck Serono S.A.S, France
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01082354
First received: March 5, 2010
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Infant, Small for Gestational Age
Drug: recombinant somatropin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
    • Tolerance
    • Concomitant treatments


Enrollment: 152
Study Start Date: March 2009
Estimated Study Completion Date: July 2021
Estimated Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: recombinant somatropin
    as per standard practice
    Other Name: 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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01082354

Locations
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, France
Sponsors and Collaborators
Merck KGaA
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
  More Information

No publications provided

Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT01082354     History of Changes
Other Study ID Numbers: IMP28018
Study First Received: March 5, 2010
Last Updated: August 21, 2012
Health Authority: France: Haute Autorité de Santé Transparency Commission

Keywords provided by Merck KGaA:
Infant, Low birth weight
Infant, Low birth height
Infant, Small for Gestational Age

ClinicalTrials.gov processed this record on April 16, 2014