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OpenTrials
Completed

NCT Number: NCT00699855

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

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).

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Key information

Conditions

Growth Hormon Deficiency Turner Syndrome in Pre-pubertal Children

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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 outcomes

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

    Time frame: Yearly

Sponsors and collaborators

Lead sponsor

Merck KGaA, Darmstadt, Germany

Industry

Registry information

Official study 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

Acronym: PREDICT LT FUP

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Jun 18, 2008
Registry last updated
Feb 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.