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RAVICTI for Urea Cycle Deficiencies
Study Summary
This trial will compare the safety and tolerability of two drugs for urea cycle disorders. It will last 25 weeks and include periods where subjects take one drug, then the other, and then both drugs.
- Urea Cycle Deficiencies
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2017 Phase 4 trial • 27 Patients • NCT02246218Trial Design
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Who is running the clinical trial?
Frequently Asked Questions
What medical conditions is RAVICTI most regularly employed to address?
"RAVICTI is successful at treating enzymes, carbamyl phosphate and citrullinemia."
How many facilities are responsible for the management of this clinical research?
"Patients are being actively recruited for this trial at University of Florida (UF) - Shands Hospital in Gainesville, Children's Hospital of Pittsburgh of UPMC in Pittsburgh, and the University of Texas Southwestern Medical Centre in Dallas. Additionally, there are two other sites participating."
Has RAVICTI been sanctioned by the FDA?
"Thanks to a successful Phase 4 trial, our team at Power have assigned RAVICTI a score of 3 on their safety scale."
How many participants are currently in the clinical trial?
"This trial necessitates 18 eligible participants, who are able to attend one of two sites: the University of Florida (UF) - Shands Hospital in Gainesville or Children's Hospital of Pittsburgh at UPMC in Pennsylvania."
Is this endeavor a pioneering investigation?
"Since 2018, RAVICTI has been the subject of medical research. Horizon Therapeutics, LLC was responsible for initiating this exploration in a Phase 1 trial involving 18 participants. As a result of its success, it achieved approval by Phase 4 regulations and is now being trialled across 6 countries, with 5 live trials hosted in 12 cities."
Have any other studies been conducted to investigate the efficacy of RAVICTI?
"RAVICTI was initially trialled in 2018 at the Azienda Ospedaliera Universitaria Di Padova, U.O.C. Malattie Metaboliche Ereditarie, Dipartimento della Salute della Donna e del Bambino facility and a total of 30 trials have been concluded since then. Currently, there are 5 active studies with a notable concentration located in Gainesville, Florida."
Are there still opportunities for patients to partake in this experiment?
"The trial is currently seeking candidates, as indicated on clinicaltrials.gov; it was initially posted on February 20th 2018 and modified most recently on April 14th 2022."
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