PK and PD Study of LUM-201 in Children With Idiopathic Growth Hormone Deficiency: (OraGrowtH212) (NCT04806854) | Clinical Trial Compass
Active — Not RecruitingPhase 2
PK and PD Study of LUM-201 in Children With Idiopathic Growth Hormone Deficiency: (OraGrowtH212)
Chile24 participantsStarted 2021-07-14
Plain-language summary
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).
Who can participate
Age range4 Years – 9 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Have a chronological age ≥ 4.0 years and ≤ 10.0 years for girls and ≤ 12.0 years for boys.
* Have a minimum body weight of 16 kg at the time of screening.
* Have a bone age examination at screening or within the 6 months prior to screening that is delayed with respect to chronological age. Bone age should be based on the apparent BA of the proximal and distal phalanges, as opposed to the metacarpals, carpals and distal forearm. A central BA reader will make the final determination on BA eligibility.
* Have HT-SDS ≤ -2.0 or a HT-SDS ≥ 2 SD below mean parental HT-SDS. If the other data (slow HV, low IGF-1, peak GH \< 10, and 6-month BA delay) are all consistent with idiopathic GHD, the subject may be enrolled with a height SDS \> -2.0 after consultation with the MMs.
* Have an accurate baseline height velocity ≤ 5.5 cm/year based on at least 6-months of growth, if available
* Within the past 6 months have a maximal GH response \> 3 and \< 10 ng/mL from at least one prior GH stimulation test within the past 6 months
* Have prepubertal status as evidenced by Tanner Stage I breast development in girls and testicular volume \< 4.0 mL in boys.
* Have an arm span to height ratio \> 96.5%
* In girls, have genetic testing results to rule out Turner syndrome. If SHOX genetic testing results are available, they need to be negative.
* Have normal thyroid function. Subjects diagnosed with hypothyroidism must have documented successful treatment for at least 30 days p…
What they're measuring
1
Evaluation of Augmented Growth Hormone (GH) Pulsatility