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Not Yet Recruiting NCT07129759

Phase 3 Long Term Safety Extension Study of LUM-201 in Children With Growth Hormone Deficiency

Conditions: Growth Hormone Deficiency (GHD)

Sex: All
Ages: 4 Years – 12 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 150
Sponsor: Lumos Pharma

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.

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07129759). StuddyBuddy aggregates publicly available trial information.