A Long-Term Safety Trial of LUM-201 in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed a LUM-201 Clinical Trial (OraGrowtH211) (OraGrowtH211)
Growth Hormone Deficiency
About this trial
This is an interventional treatment trial for Growth Hormone Deficiency focused on measuring LUM-201, PGHD, GHD, Growth hormone secretagogue, Oral, Height
Eligibility Criteria
Inclusion Criteria: Parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable. Must have successfully participated in a pediatric LUM-201 GHD study through at least the 12-month visit, and be eligible for continuation of treatment, pending all other enrollment criteria are met. Exclusion Criteria: Medical or genetic condition that, in the opinion of the PI and/or MMs, adds unwarranted risk to the use of LUM-201 Has planned or is receiving current long-term treatment with medications known to act as substrates, inducers, or inhibitors of the cytochrome system CYP3A4 that metabolizes LUM-201. Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the PI in consultation with the MMs.
Sites / Locations
- University of Iowa
- University of South Carolina
Arms of the Study
Arm 1
Experimental
LUM-201 (1.6 mg/kg/day)