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Clinical Trials/EUCTR2004-005054-31-IT
EUCTR2004-005054-31-IT
Active, not recruiting
Not Applicable

A phase IV open-label study of predictive markers in Growth Hormone Deficient and Turner Syndrome pre-pubertal children treated with SAIZEN.

INDUSTRIA FARMACEUTICA SERONO0 sites326 target enrollmentSeptember 20, 2005
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ConditionsGrowth failure in children caused by decreased or absent secretion of endogenous growth hormone - growth failure due to Tunner Syndrome.MedDRA version: 6.1Level: PTClassification code 10056438
DrugsSAIZEN 8 CLICK*1FL 8MG+1CART

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Growth failure in children caused by decreased or absent secretion of endogenous growth hormone - growth failure due to Tunner Syndrome.
Sponsor
INDUSTRIA FARMACEUTICA SERONO
Enrollment
326
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 20, 2005
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
INDUSTRIA FARMACEUTICA SERONO

Eligibility Criteria

Inclusion Criteria

  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) no
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Not specified

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A phase IV open-label study of predictive markers in Growth Hormone Deficient and Turner Syndrome prepubertal children treated with Saize- growth failure in children caused by decreased or absent secretion of endogenous growth hormone.- growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis.MedDRA version: 7.1Level: PTClassification code 10056438
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A phase IV open-label study of predictive markers in Growth Hormone Deficient and Turner Syndrome prepubertal children treated with SAIZEN.Estudio abierto en fase IV sobre marcadores predictivos en niños prepuberales con Déficit de Hormona de Crecimiento y síndrome de Turner tratados con Saizen R. - Predictive markers in GHD and TS children treated with SAIZEN.
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A phase IV open-label study of predictive markers in Growth Hormone Deficient and Turner Syndrome prepubertal children treated with Saize- growth failure in children caused by decreased or absent secretion of endogenous growth hormone.- growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis.MedDRA version: 7.1Level: PTClassification code 10056438
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A phase IV open-label study of predictive markers in Growth Hormone Deficient and Turner Syndrome prepubertal children treated with Saize- growth failure in children caused by decreased or absent secretion of endogenous growth hormone.- growth failure in girls with gonadal dysgenesis (Turner Syndrome), confirmed by chromosomal analysis.MedDRA version: 7.1Level: PTClassification code 10056438
EUCTR2004-005054-31-FISerono International S.A.326