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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT00699855
First received: June 13, 2008
Last updated: February 17, 2014
Last verified: February 2014
  Purpose

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).


Condition
Growth Hormon Deficiency
Turner Syndrome in Pre-pubertal Children

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Merck KGaA:

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). [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • When available laboratory parameters such as IGF-1, IGFPB-3, fasting glucose, fasting insulin, TSH and T4 will also be collected. [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Enrollment: 182
Study Start Date: September 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

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

Subjects initially enrolled in PREDICT (NCT 00256126) clinical study and continuing a growth hormone treatment.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699855

Sponsors and Collaborators
Merck KGaA
Investigators
Study Director: Gilles Della Corte Merck Serono S.A., Geneva
  More Information

Publications:
Responsible Party: Merck KGaA
ClinicalTrials.gov Identifier: NCT00699855     History of Changes
Other Study ID Numbers: 28614
Study First Received: June 13, 2008
Last Updated: February 17, 2014
Health Authority: France: Ministry of Health

Keywords provided by Merck KGaA:
Growth Hormon Deficiency and
Turner Syndrome in pre-pubertal children
Long term follow-up of predictive markers

Additional relevant MeSH terms:
Gonadal Dysgenesis
Primary Ovarian Insufficiency
Syndrome
Turner Syndrome
Adnexal Diseases
Cardiovascular Abnormalities
Cardiovascular Diseases
Chromosome Disorders
Congenital Abnormalities
Disease
Disorders of Sex Development
Endocrine System Diseases
Genetic Diseases, Inborn
Genital Diseases, Female
Gonadal Disorders
Heart Defects, Congenital
Heart Diseases
Ovarian Diseases
Pathologic Processes
Sex Chromosome Disorders
Sex Chromosome Disorders of Sex Development
Urogenital Abnormalities

ClinicalTrials.gov processed this record on November 24, 2014