Clareo Health | A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ascendis Pharma Endocrinology Division A/S
Age
3–12
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Prepubertal children with GHD (either isolated or as part of a multiple pituitary hormone deficiency) in Tanner stage 1 (Tanner 1982) aged:
* Boys: 3-12 years, inclusive
* Girls: 3-11 years, inclusive
Impaired height (HT) defined as at least 2.0 standard deviations (SD) below the mean height for chronological age and sex (HT SDS ≤ -2.0) according to the 2000 CDC Growth Charts for the United States Methods and Development, available at http://www.cdc.gov/growthcharts/
Diagnosis of GHD confirmed by 2 different GH stimulation tests, defined as a peak GH level of ≤10 ng/mL, determined with a validated assay
Bone age (BA) at least 6 months less than chronological age
Baseline IGF-1 level of at least 1 SD below the mean IGF-1 level standardized for age and sex (IGF-1 SDS ≤-1)
Written, signed informed consent of the parent(s) or legal guardian(s) of the subject and written assent of the subject (if the subject is able to read, understand, and sign)
You may not be if
Children with a body weight below 12 kg
Prior exposure to recombinant hGH or IGF-1 therapy
Children with past or present intracranial tumor growth as confirmed by a sellar MRI scan (with contrast) at Screening (MRI results from up to 6 months prior to Screening may be accepted)
Children with psychosocial dwarfism
Children with idiopathic short stature
History or presence of malignant disease; any evidence of present tumor growth
Closed epiphyses
Major medical conditions and/or presence of contraindication to hGH treatment
Participation in any other trial of an investigational agent within 3 months prior to Screening
