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
An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children With Idiopathic Growth Hormone Deficiency
1 other identifier
interventional
60
2 countries
7
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Aug 2023
Longer than P75 for phase_2
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 19, 2023
CompletedFirst Posted
Study publicly available on registry
April 3, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2028
February 15, 2024
February 1, 2024
4.6 years
March 19, 2023
February 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events
Number of events
Day 1 to Month 36
Secondary Outcomes (6)
Growth Hormone Concentrations in subjects
Day 1 to Month 36
Insulin-like growth factor 1 concentration
Day 1 to Month 36
Height standard deviation score (SDS)
Day 1 to Month 36
Change in Weight SDS
Day 1 to Month 36
Annualized Height Velocity (AHV) achieved by daily dosing 1.6mg/kg of LUM-201
Day 1 to Month 36
- +1 more secondary outcomes
Study Arms (1)
LUM-201 (1.6 mg/kg/day)
EXPERIMENTALInterventions
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lumos Pharmalead
Study Sites (7)
University of Iowa
Iowa City, Iowa, 52242, United States
UMass Memorial Medical Center
Worcester, Massachusetts, 01655, United States
Children's Mercy Hospital
Kansas City, Missouri, 64111, United States
University of South Carolina
Charleston, South Carolina, 29425, United States
Texas Tech University Health Sciences Center
Amarillo, Texas, 79106, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
Canberra Hospital
Garran, Australian Capital Territory, 2605, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 19, 2023
First Posted
April 3, 2023
Study Start
August 1, 2023
Primary Completion (Estimated)
March 1, 2028
Study Completion (Estimated)
April 1, 2028
Last Updated
February 15, 2024
Record last verified: 2024-02