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

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.