EUCTR2004-005223-18-DEActive, not recruitingNot Applicable
Evaluation of growth response in short children suffering from a disease with growth retardation and treated with Somatropin: A prospective, longitudinal non-randomised, open, phase II study
Childrens´ Hospital Erlangen0 sites120 target enrollmentStarted: March 7, 2005Last updated:
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 120
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Inclusion criteria for request of GH treatment:
- •Severe growth retardation (< -2,5 height SDS and annual growth velocity (HV- SDS): < 0 SD according to Reinken (1992) and parental adjusted target height < –1 SD according to Tanner (1986)
- •Chronological age > 4 and < 10 years, prepubertal children; for girls: Tanner breast stage B = 1, for boys: testis volume = 3 ml
- •Any disease which is NOT part of the registered indications for GH treatment in Germany
- •Written informed consent from both parents and from the patients if she/he is able to receive and understand the information
- •GH treatment requested by an expert in pediatric endocrinology
- •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
- •Exclusion criteria for request of GH treatment:
- •Participation in any other clinical study
- •Unable to follow the and/or comprehend the protocol ( e.g. severe mental retardation)
- •Previous history of intolerance or hypersensitivity to the study drug
- •History of malignancy
- •Chromosomal anomalies with increased risk for malignancy
Investigators
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