Growth Response in Short Children Suffering From a Disease With Growth Retardation and Treated With Somatropin

• Status: Completed
• Trial end date: 2011-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Growth hormone therapy will improve the height of short statured children with pathological conditions that lead to growth retardation. Growth hormone therapy will show an increase in height velocity >1 SD compared to pretreatment height velocity. and the therapy will be safe.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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