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Long Term Follow up Study of Predictive Markers in GHD and TS Children (PREDICT LT FUP)

Primary Purpose

Growth Hormon Deficiency, Turner Syndrome in Pre-pubertal Children

Status
Completed
Phase
Locations
Study Type
Observational
Intervention
Sponsored by
Merck KGaA, Darmstadt, Germany
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Growth Hormon Deficiency focused on measuring Growth Hormon Deficiency and, Turner Syndrome in pre-pubertal children, Long term follow-up of predictive markers

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have completed the PREDICT study (NCT 00256126)
  • Followed up at least 1 year when still under treatment after completion of PREDICT Trial
  • Parent's or guardian's written consent given before any data collection

Exclusion Criteria:

  • Use of an investigational drug or participation in another interventional clinical trial since discontinuation of PREDICT trial

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Data such as auxological parameters (height, weight, Tanner stage, bone age) will be collected as well as GH treatment use (including dose and adherence to the treatment).

    Secondary Outcome Measures

    When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected.

    Full Information

    First Posted
    June 13, 2008
    Last Updated
    February 17, 2014
    Sponsor
    Merck KGaA, Darmstadt, Germany
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00699855
    Brief Title
    Long Term Follow up Study of Predictive Markers in GHD and TS Children
    Acronym
    PREDICT LT FUP
    Official Title
    Observational Long-term Follow-up of the Phase IV Open-label Trial of Predictive Markers in GHD and TS Pre-pubertal Children Treated With Saizen
    Study Type
    Observational

    2. Study Status

    Record Verification Date
    February 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2008 (undefined)
    Primary Completion Date
    August 2012 (Actual)
    Study Completion Date
    August 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Merck KGaA, Darmstadt, Germany

    4. Oversight

    5. Study Description

    Brief Summary
    Primary objective is to assess the relationship between changes from serum biomarkers observed after 1 month of Saizen® therapy and change in height, weight after up to 5 years of treatment with Growth Hormone in children with Growth Hormone Deficiency (GHD) and Turner Syndrome (TS).
    Detailed Description
    This study is an observational study that will collect data from patients enrolled in a previous study (PREDICT, NCT 00256126). Data such as auxological parameters (height, weight, Tanner stage, bone age will be collected as well as GH treatment use (including dose and adherence to the treatment). Because for some countries the start of this long term follow up study will take place more than one year after subjects have completed the initial study (PREDICT) retrospective data may be collected (if subjects agree) as well as prospective data. When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected. This data will be collected yearly during the normal follow up visits during 5 years.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Growth Hormon Deficiency, Turner Syndrome in Pre-pubertal Children
    Keywords
    Growth Hormon Deficiency and, Turner Syndrome in pre-pubertal children, Long term follow-up of predictive markers

    7. Study Design

    Enrollment
    182 (Actual)
    Primary Outcome Measure Information:
    Title
    Data such as auxological parameters (height, weight, Tanner stage, bone age) will be collected as well as GH treatment use (including dose and adherence to the treatment).
    Time Frame
    Yearly
    Secondary Outcome Measure Information:
    Title
    When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected.
    Time Frame
    Yearly

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Have completed the PREDICT study (NCT 00256126) Followed up at least 1 year when still under treatment after completion of PREDICT Trial Parent's or guardian's written consent given before any data collection Exclusion Criteria: Use of an investigational drug or participation in another interventional clinical trial since discontinuation of PREDICT trial
    Study Population Description
    Subjects initially enrolled in PREDICT (NCT 00256126) clinical study and continuing a growth hormone treatment.
    Sampling Method
    Non-Probability Sample
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gilles Della Corte
    Organizational Affiliation
    Merck Serono S.A., Geneva
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23761422
    Citation
    Clayton P, Chatelain P, Tato L, Yoo HW, Ambler GR, Belgorosky A, Quinteiro S, Deal C, Stevens A, Raelson J, Croteau P, Destenaves B, Olivier C. A pharmacogenomic approach to the treatment of children with GH deficiency or Turner syndrome. Eur J Endocrinol. 2013 Jul 29;169(3):277-89. doi: 10.1530/EJE-13-0069. Print 2013 Sep.
    Results Reference
    result
    PubMed Identifier
    34045667
    Citation
    Stevens A, Murray P, De Leonibus C, Garner T, Koledova E, Ambler G, Kapelari K, Binder G, Maghnie M, Zucchini S, Bashnina E, Skorodok J, Yeste D, Belgorosky A, Siguero JL, Coutant R, Vangsoy-Hansen E, Hagenas L, Dahlgren J, Deal C, Chatelain P, Clayton P. Gene expression signatures predict response to therapy with growth hormone. Pharmacogenomics J. 2021 Oct;21(5):594-607. doi: 10.1038/s41397-021-00237-5. Epub 2021 May 27.
    Results Reference
    derived
    PubMed Identifier
    29618660
    Citation
    Murray PG, Stevens A, De Leonibus C, Koledova E, Chatelain P, Clayton PE. Transcriptomics and machine learning predict diagnosis and severity of growth hormone deficiency. JCI Insight. 2018 Apr 5;3(7):e93247. doi: 10.1172/jci.insight.93247. eCollection 2018 Apr 5.
    Results Reference
    derived
    PubMed Identifier
    26503811
    Citation
    De Leonibus C, Chatelain P, Knight C, Clayton P, Stevens A. Effect of summer daylight exposure and genetic background on growth in growth hormone-deficient children. Pharmacogenomics J. 2016 Nov;16(6):540-550. doi: 10.1038/tpj.2015.67. Epub 2015 Oct 27.
    Results Reference
    derived
    PubMed Identifier
    26340968
    Citation
    Valsesia A, Chatelain P, Stevens A, Peterkova VA, Belgorosky A, Maghnie M, Antoniazzi F, Koledova E, Wojcik J, Farmer P, Destenaves B, Clayton P; PREDICT Investigator group. GH deficiency status combined with GH receptor polymorphism affects response to GH in children. Eur J Endocrinol. 2015 Dec;173(6):777-89. doi: 10.1530/EJE-15-0474. Epub 2015 Sep 4.
    Results Reference
    derived

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    Long Term Follow up Study of Predictive Markers in GHD and TS Children

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