Growth Hormone Deficiency Clinical Trial
— OraGrowtH213Official title:
A Multicenter, Open-Label, Phase 2 Study to Evaluate Growth and Safety of LUM-201 Following 12 Months of Daily rhGH Treatment in Children With Idiopathic Growth Hormone Deficiency Who Have Previously Completed the LUM-201-01 Trial
Verified date | February 2024 |
Source | Lumos Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a multi-national trial. The goals of the trial are to study the growth response to LUM-201 administration in children with idiopathic growth hormone deficiency (GHD) previously treated with daily rhGH for 12 months in the LUM-201-01 trial.
Status | Active, not recruiting |
Enrollment | 18 |
Est. completion date | February 2025 |
Est. primary completion date | February 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 13 Years |
Eligibility | Inclusion Criteria: - Parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable. - Must have previously completed 12 months of daily rhGH treatment as part of the LUM-201-01 PGHD trial. - Is eligible for study participation as confirmed by the principal investigator (PI) Exclusion Criteria: - Has a medical condition that, in the opinion of the PI and/or MM, adds unwarranted risk to use of LUM-201. - Uses any medication that, in the opinion of the PI and/or MM, can independently cause short stature or limit the response to exogenous growth factors. - 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 |
Country | Name | City | State |
---|---|---|---|
Poland | Klinika Endokrynologii i Chorob Metabolicznych, Instytut Centrum Zdrowia Matki Polki | Lodz | |
Poland | Sonomed - Centrum Medyczne | Szczecin | |
Poland | Klinika Endokrynologii i Diabetologii, Instytut "Pomnik Centrum Zdrowia Dziecka | Warsaw | |
United States | University of Virginia Health System | Charlottesville | Virginia |
United States | Nationwide Children's Hospital | Columbus | Ohio |
United States | Indiana University School of Medicine | Indianapolis | Indiana |
United States | The Children's Mercy Hospital | Kansas City | Missouri |
United States | M Health, Fairview Pediatric Specialty Clinics- Discovery Clinic | Minneapolis | Minnesota |
United States | Rady Children's Hospital | San Diego | California |
United States | Children's National Hospital | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Lumos Pharma |
United States, Poland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Annualized height velocity (AHV) measured as standing height with stadiometer | Annualized Height Velocity (AHV) measured as standing height with stadiometer | Day 1 to Month 12 | |
Secondary | Incidence of adverse events in children with GHD | Number of events | Day 1 to Month 12 | |
Secondary | GH Concentration on maintenance treatment | Serum GH concentration | Day 1 to Month 12 | |
Secondary | Insulin-like growth factor 1 | Serum concentrations of insulin-like growth factor 1 | Day 1 to Month 12 | |
Secondary | Insulin-like growth factor binding protein 3 | Serum concentrations of insulin-like growth factor binding protein 3 | Day 1 to Month 12 | |
Secondary | Height standard deviation score (SDS) | Change in HT-SDS | Day 1 to Month 12 | |
Secondary | Change in Weight | Change in Weight | Day 1 to Month 12 | |
Secondary | Change in Weight-SDS | Change in Weight-SDS | Day 1 to Month 12 | |
Secondary | Change in BMI | Change in BMI | Day 1 to Month 12 | |
Secondary | Change in BMI SDS | Change in BMI SDS | Day 1 to Month 12 | |
Secondary | Change in Bone Age | Change in bone age, measured by X-ray of left hand and wrist using Greulich & Pyle atlas | Month 6 | |
Secondary | Insulin-like growth factor 1 standard deviation score (SDS) | Change in IGF-1 SDS | Day 1 to Month 12 |
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