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A Multicenter, 24-Month, Randomized, Open-Label, Active Control, Parallel Arm, Phase 2 Study of Daily Oral LUM-201 in Naïve-to-Treatment, Prepubertal Children with Idiopathic Growth Hormone Deficiency (GHD)

This is a randomized drug study that will examine if there is a difference between a daily oral LUM- 201 (study drug) and the standard of care drug, Norditropin, over a 24 month period in children, who have not received treatment for Growth Hormone Deficiency (GHD)

There will be 15 visits, 4 will be remote and 11 in-person. Blood will be drawn at 8 of the visits.

$900

Daniel Hale
Brennen Harding - at bharding@pennstatehealth.psu.edu or 717-531-5656
 

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Younger than 18 years old
This study is NOT accepting healthy volunteers
NCT04614337
STUDY00016181
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Inclusion Criteria:
Have an established diagnosis of PGHD. Eligible subjects must be naïve-to-treatment and be prepubertal.
At Screening, be age ≥ 3.0 years and age < 10.0 years for girls and < 11.0 years for boys
Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 30 days prior to Day 1.
Exclusion Criteria:
A diagnosis of Attention Deficit Hyperactivity Disorder (ADHD) and/or use of medication to treat ADHD
Evidence or history of an intracranial mass
Children's Health, Diabetes & Hormones
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Location Contacts
Hershey, PA ,