Validation study for genetic markers for growth hormone treatment in growth hormone deficient and turner syndrome patients

• Conditions: Idiopathic growth hormone deficienty Turner Syndrome; MedDRA version: 14.1Level: SOCClassification code 10014698Term: Endocrine disordersSystem Organ Class: 10014698 - Endocrine disorders; MedDRA version: 14.1Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disorders; MedDRA version: 14.1Level: SOCClassification code 10010331Term: Congenital, familial and genetic disordersSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 14.1Level: PTClassification code 10045181Term: Turner's syndromeSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2011-000460-10-IT
• Lead Sponsor: MERCK SERONO SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02-27
• Last Update Posted: 10 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 395

Inclusion Criteria

1) Pre-established diagnosis of IGHD or TS based on classical criteria with at least 1 year of r-hGH therapy and with Tanner stage 1 at treatment start 2) Retrospective availability of a complete set of clinical, auxological and biological parameters necessary for building the predictive model
Are the trial subjects under 18? yes
Number of subjects for this age range: 350
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1) Acquired GHD 2) Any drug or disease that could affect growth

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified