An Extension Study to Monitor Long-Term Safety of LUM-201 Treatment in Children with Idiopathic Growth Hormone Deficiency - LUM-201-02

umos Pharma Inc.0 个研究点目标入组 69 人开始时间: 2023年6月5日最近更新: 2024年8月21日

适应症

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•1. Parent/caregiver must sign the informed consent, and the subject must sign the assent, as applicable., 2. Must have successfully participated in a pediatric LUM-201 GHD study through at least the 12-month visit, and be eligible for continuation of treatment, pending all other enrollment criteria are met. Specific enrollment criteria for subjects in each LUM-201 trial are listed below. Subjects transitioning from the LUM-201-01 trial will be considered eligible for enrollment pending successful participation in the LUM-201-01 trial, having met an AHV of = 6.7 cm/year after 12 months of LUM-201 therapy. Subjects transitioning from the LUM-201-04 trial will be considered eligible for enrollment pending successful completion of 12 months of therapy with rhGH on the LUM-201-01 trial, followed by 12 months of treatment with LUM-201 in the LUM-201-04 trial and having met an AHV of = 80% of first year growth on rhGH., 3. Subjects who are sexually active must use an acceptable form of contraception., 4. Is eligible for a Day 1 visit as confirmed by the principal investigator (PI).

•1. Has a medical or genetic condition that, in the opinion of the PI and/or MMs, adds unwarranted risk to use of LUM-201., 2. 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 (see Appendix 1 of protocol 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 PI in consultation with the MMs.

发起方

umos Pharma Inc.