Long Term Follow up Study of Predictive Markers in GHD and TS Children (PREDICT LT FUP)
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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 |
- 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 ]
- 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: | 211 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
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 |
Subjects initially enrolled in PREDICT (NCT 00256126) clinical study and continuing a growth hormone treatment.
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 More Information
No publications provided
| Responsible Party: | Merck KGaA |
| ClinicalTrials.gov Identifier: | NCT00699855 History of Changes |
| Other Study ID Numbers: | 28614 |
| Study First Received: | June 13, 2008 |
| Last Updated: | May 15, 2012 |
| 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:
|
Turner Syndrome Gonadal Dysgenesis Primary Ovarian Insufficiency Disorders of Sex Development Urogenital Abnormalities Sex Chromosome Disorders of Sex Development Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases |
Congenital Abnormalities Sex Chromosome Disorders Chromosome Disorders Genetic Diseases, Inborn Gonadal Disorders Endocrine System Diseases Ovarian Diseases Adnexal Diseases Genital Diseases, Female |
ClinicalTrials.gov processed this record on June 18, 2013