Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT03895528
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of HGPS or progeroid laminopathy by qualified medical doctor (based on common phenotype as described in Gordon 2015 and Merideth 2008). Confirmation with genetic testing is preferred but not required.
* Adequate hepatic function as defined by SGPT (ALT) and SGOT (AST) ≤ 5 times upper limit of normal range for age
Exclusion Criteria:
* Taking medications or foods that are known to be moderate or strong inducers or inhibitors of CYP3A4 or sensitive CYP3A substrates; or if a patient is taking one of these drugs and cannot safely discontinue or take an alternative drug, the dose of the inhibitor/inducer must be adjusted per the treating physician
* Taking digoxin, a P-gp substrate with a narrow therapeutic window.
* Severe renal impairment (GFR \< 30 mL/min/1.73m2).
* Uncontrolled infection.
* Presence of any active clinically relevant medical condition that in the opinion of the treating physician would preclude patient from safely participating in the program.
* Pregnant or breast-feeding or plan to become pregnant while on therapy.
Sex:
ALL
Minimum Age:
12 Months
Study:
NCT03895528
Study Brief:
Protocol Section:
NCT03895528