Clinical Trial Details
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NCT01947907 : Safety, PK/PD and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)
PhasePhase 2
AgesMin: 3 Years Max: 12 Years
Inclusion Criteria:

- Prepubertal children, Tanner stage 1

- Diagnosis of GHD, confirmed by two stimulation tests

- Bon age not greater than chronological age

- Impaired height and height velocity

- BMI within +/- 2 SD

- Baseline IGF-I

- Normal fundoscopy

- Stable hormonal replacement therapy (other than hGH)

- Written Informed Consent

Exclusion Criteria:

- Prior exposure to rhGH or IGF-I

- Past or present intracranial tumor; history or presence of malignant disease

- Small for gestational age (SGA)

- Malnutrition

- Psychosocial dwarfism

- Coeliac disease

- Anti-hGH antibodies

- Diabetes mellitus

- Chromosomal abnormalities (e.g. Turner syndrome, SHOX)

- Closed epiphyses

- Known or suspected HIV infection
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