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An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children With Idiopathic Growth Hormone Deficiency
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.
An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency. This study will last for up to 36 months to allow collection of additional long-term safety and efficacy data related to LUM-201 treatment in the pediatric patient population. Subjects will enter into this trial after successful participation in a prior LUM-201 study. This study will consist of visits every 6 months through three years. There are a total of 7 in-person visits with a follow-up phone call between visits. At the clinic visits, subjects will have a physical exam and blood collection as well as efficacy assessments.
Age
5 - 14 years
Sex
ALL
Healthy Volunteers
No
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
Start Date
August 1, 2023
Primary Completion Date
March 1, 2028
Completion Date
April 1, 2028
Last Updated
February 15, 2024
60
ESTIMATED participants
LUM-201
DRUG
Lead Sponsor
Lumos Pharma
NCT07333521
NCT00227253
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06109935