Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency (NCT07129759) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency
150 participantsStarted 2026-09
Plain-language summary
This is a Multi-national Trial. The Goal of the Trial is to Offer Subjects Who Complete 12 Months in the LUM-201-10 Phase 3 Trial up to an Additional 36 Months of Treatment of LUM-201 While Evaluating Safety and Tolerability of LUM-201.
Who can participate
Age range4 Years – 12 Years
SexALL
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Inclusion Criteria:
* Parent/caregiver must be willing to provide written informed consent, and the subject must sign the assent, as applicable.
* Subject must have successfully completed 12 months of participation in the LUM-201 Phase 3 GHD trial, and be eligible for continuation of treatment, pending all other enrollment criteria are met.
* Subject who is sexually active must use an acceptable form of contraception.
* Subject must be eligible for the Day 1 visit as confirmed by the Investigator.
Exclusion Criteria:
* Subject has a medical or genetic condition that, in the opinion of the Investigator and/or MMs, adds unwarranted risk to use of LUM-201.
* Pregnancy.
* Subject has planned or is receiving current long-term treatment with medications known to prolong the QT interval or act as substrates, inducers, or inhibitors of the cytochrome system cytochrome P450 type 3A4 that metabolizes LUM-201 (see Appendix 6 for list of example medications). Subjects receiving shorter-term (two weeks or less) treatment with these medications should be evaluated on case-by-case basis by the Investigator in consultation with the MMs.
What they're measuring
1
To evaluate the long-term safety and tolerability of LUM-201