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Clinical Trials in Australia / NCT05796440
Enrolling by invitation Phase 2

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)

NCT05796440 · tracked via the Priya Life Science Australia tracker
Sponsor
Lumos Pharma
Phase
Phase 2
Started
2023-08-01
Last updated
2024-02-15

Condition(s) studied

Growth Hormone Deficiency

Investigational drug(s) / intervention(s)

LUM-201 →

LUM-201: Administered orally once daily

Study summary

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.

Eligibility

Sex
ALL
Min age
5 Years
Max age
14 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Incidence of treatment-emergent adverse events — Day 1 to Month 36
    Number of events

Trial sites (7)

FacilityCityRegionStatus
University of Iowa Iowa City Iowa
UMass Memorial Medical Center Worcester Massachusetts
Children's Mercy Hospital Kansas City Missouri
University of South Carolina Charleston South Carolina
Texas Tech University Health Sciences Center Amarillo Texas
Seattle Children's Hospital Seattle Washington
Canberra Hospital Garran Australian Capital Territory

More Lumos Pharma trials in Australia

Phase 3 Study of LUM-201 in Children With Growth Hormone Deficiency Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05796440 on ClinicalTrials.gov ↗ ← All trials in Australia