ARCT-810 for OTC Deficiency
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you must stop taking your current medications, but you must have been on a stable treatment for OTC deficiency for at least 28 days before joining. Changes in these therapies close to the trial start are not allowed.
How is the drug ARCT-810 unique in treating OTC deficiency?
What is the purpose of this trial?
Evaluate the safety and pharmacodynamics of multiple doses of ARCT-810 in adolescent and adult participants with OTC deficiency.
Eligibility Criteria
This trial is for adolescents and adults aged 12 or older with Ornithine Transcarbamylase Deficiency (OTCD). Participants must be on a stable diet and/or medication regimen for OTCD, in good health, and willing to follow the study's procedures. They cannot have severe allergies to liposomal/PEG products, drug/alcohol abuse history, certain infections or uncontrolled conditions like hypertension.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Diet Stabilization
Participants undergo a diet stabilization period before treatment
Treatment
Participants receive up to 5 IV infusions of ARCT-810 every two weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- ARCT-810
Find a Clinic Near You
Who Is Running the Clinical Trial?
Arcturus Therapeutics, Inc.
Lead Sponsor