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 · Phase 2
Conditions studied: Growth Hormone Deficiency
In brief
This is a multi-national trial. The trial aims to study the long-term safety of LUM-201 in subjects with Idiopathic Pediatric Growth Hormone Deficiency (iPGHD). This study will also assess pharmacodynamics and efficacy response to therapy with LUM-201.
Key facts
- Study ID
- NCT05796440
- Run by
- Lumos Pharma
- People needed
- 60
- Starts
- 2023-08-01
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2024-02-15
Who can join
Age: 5 and older, up to 14. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of Iowa — Iowa City, Iowa, United States
- UMass Memorial Medical Center — Worcester, Massachusetts, United States
- Children's Mercy Hospital — Kansas City, Missouri, United States
- University of South Carolina — Charleston, South Carolina, United States
- Texas Tech University Health Sciences Center — Amarillo, Texas, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- Canberra Hospital — Garran, Australian Capital Territory, Australia
Full record on ClinicalTrials.gov
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