Trial · Interventional
Active, not recruitingPhase 2Registry dataPK and PD Study of LUM-201 in Children With Idiopathic Growth Hormone Deficiency: (OraGrowtH212)
Short name OraGrowtH212
Overview
- Status
- Active, not recruiting
- Phase
- Phase 2
- Enrollment
- 24 participants (estimated)
- Sponsor
- Lumos Pharma · Industry
- Design
- Randomized · Open label (no masking)
- Countries
1 country
Chile
- Start
- 14 Jul 2021
- Primary completion
- Apr 2030 (estimated)
- Completion
- Jul 2030 (estimated)
- First posted
- 19 Mar 2021
- Last update posted
- 4 Oct 2023
- Conditions
- Growth Hormone Deficiency
Timeline
1 trial · 1 ongoing
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 2
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
The goals of this single site trial are to study the pharmacokinetics (PK) and pharmacodynamics of LUM-201 and effects of LUM-201 administration on growth hormone release over time in children with idiopathic pediatric growth hormone deficiency (PGHD).
Interventions
- LUM-201Drug
Arms2
Experimental
LUM-201 (1.6 mg/kg/day)
Experimental
LUM-201 (3.2 mg/kg/day)
Primary outcomes2
Outcomes the sponsor listed as primary.
Evaluation of Augmented Growth Hormone (GH) Pulsatility
Time frame · Day 1 to Month 6
Registry description
12-hour mean GH concentration
Pharmacokinetics of LUM-201 and M8
Time frame · Day 1 to Month 6
Registry description
Plasma concentrations (Cmax/Steady State)
Secondary outcomes(2)
Incidence of adverse events in children with idiopathic GHD
Time frame · up to 8 years
Registry description
Number of events
Height standard deviation score (SDS)
Time frame · Day 1 to Month 12
Registry description
Change in HT-SDS from Baseline to Month 6 and Month 12
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 4 Years up to 9 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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