NCT05796440
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)
Enrolling by Invitation
PHASE2Ages 5–14InterventionalTreatmentLumos Pharma
~60 participants
Updated 2024-02-15 on ClinicalTrials.gov
What's tested:LUM-201
At a glance
Recruiting sites
0 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of treatment-emergent adverse events
Measured over Day 1 to Month 36
Conditions
Where it's being run
7 sites across 7 statesIowa1
Massachusetts1
Missouri1
South Carolina1
Texas1
Washington1
Australian Capital Territory1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- Incidence of treatment-emergent adverse eventsDay 1 to Month 36
Number of events