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.
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.
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.
Single group
LUM-201
Drug1.6 mg/kg/day, administered orally once daily
To evaluate the long-term safety and tolerability of LUM-201
* The number of subjects with at least 1 (serious) treatment-related adverse event (TEAE). * The number of subjects with at least 1 suspected unexpected serious adverse reaction. * The number of subjects with clinically significant abnormalities related to trial laboratory tests or electrocardiograms (ECGs). * The number of subjects with at least 1 adverse event of special interest (AESI). * Annual change from baseline in body weight standard deviation score (SDS). * Annual change from baseline in body mass index (BMI) SDS.
To evaluate the long-term effect of LUM-201 on growth.
* Annual height velocity. * Annual change in height standard deviation score (SDS). * Annual change in body mass index (BMI). * Annual change in BMI SDS. * Annual change in bone age (BA)/chronological age (CA) ratio.
To evaluate the long-term effect of LUM-201 on pharmacodynamic (PD) markers.
* Annual change in insulin-like growth factor (IGF)-1 SDS. * Annual change in insulin-like growth binding protein 3 (IGFBP-3) SDS.
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This trial is not recruiting at the moment. You can still explore other options:
