NCT05868499
Rollover Study From EXG-US-01
Enrolling by Invitation
PHASE1Ages 18+InterventionalSupportive careElixirgen Therapeutics, Inc.
~12 participants
Updated 2024-07-12 on ClinicalTrials.gov
What's tested:EXG34217
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with adverse events -Safety by Incidence of Treatment-Emergent
Measured over Change from Baseline Systolic Blood Pressure at Month 18, 24,30,36,42,48,60 and 72
+4 more outcomes measured
Conditions
Where it's being run
1 sites across 1 statesOhio1
Study leadership
- Kasiani Myers, MD · PRINCIPAL_INVESTIGATOR · Cincinnati Children Hospital Medical Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
What this trial measures
- Number of participants with adverse events -Safety by Incidence of Treatment-EmergentChange from Baseline Systolic Blood Pressure at Month 18, 24,30,36,42,48,60 and 72
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03. Incidence and nature of adverse events, vital signs, weight.
- umber of participants with a change in in physical examinationChange from Baseline Systolic Blood Pressure at Month 18, 24,30,36,42,48,60 and 72
Physical examination changes General appearance ,Head, eyes, ears, nose, and throat, Respiratory, Cardiovascular, Musculoskeletal, Abdomen, Neurologic, Extremities, Dermatologic, Lymphatic)
- Number of participants with a change in Electrocardiography (ECG)Change from Baseline Systolic Blood Pressure at Month 18, 24,30,36,42,48,60 and 72
ECG (standard digital 12-lead in singlicate)
- Number of participants with a change in clinical laboratory evaluationsChange from Baseline Systolic Blood Pressure at Month 18, 24,30,36,42,48,60 and 72
Changes in clinical laboratory evaluations (Hematology, Blood chemistry, Coagulation, and Urinalysis)
- Number of participants with a change of ImmunogenicityChange from Baseline Systolic Blood Pressure at Month 18, 24,30,36,42,48,60 and 72
Change in Antibody against virus vector and transgene