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Last Updated: November 27, 2022

CLINICAL TRIALS PROFILE FOR RAVICTI


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All Clinical Trials for Ravicti

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01257737 ↗ To Evaluate the Safety of Long-term Use of HPN-100 in the Management of Urea Cycle Disorders (UCDs) Completed Horizon Therapeutics, LLC Phase 4 2010-10-04 This was an open-label, long-term safety study of HPN-100 (RAVICTI; glycerol phenylbutyrate) in participants with a urea cycle disorder (UCD) who completed the safety extensions of HPN-100-005 (NCT00947544; HPN-100-005SE), HPN-100-006 (NCT00947297; HPN-100-007), or HPN-100-012 (NCT01347073; HPN-100-012SE). The initial studies were 1- to 2-week crossover studies, and their associated safety extensions were 12-month, open-label studies. All participants who completed the initial studies were eligible to enroll in the associated safety extension studies, and new participants were also permitted to enroll directly into the safety extension studies.
NCT01347073 ↗ Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs) Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 3 2011-07-01 This non-randomized, open-label study was approximately one year in duration and consisted of a short term NaPBA to HPN-100 switchover part involving two overnight stays followed by a 12-month long term treatment period involving monthly visits.
NCT01881984 ↗ Use of Ravictiâ„¢ in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 1 2013-06-01 This is a medical research study to test a medication in adult patients with a disease called medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the 985A>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is currently FDA approved for the treatment of urea cycle disorders. Previous research suggests that Ravicti may also be effective in the treatment MCAD deficiency. This study will investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD deficiency caused by having at least one copy of the 985A>G mutation.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Ravicti

Condition Name

Condition Name for Ravicti
Intervention Trials
Urea Cycle Disorder 2
Urea Cycle Disorders 2
Byler Disease 2
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Condition MeSH

Condition MeSH for Ravicti
Intervention Trials
Urea Cycle Disorders, Inborn 4
Disease 4
Cholestasis, Intrahepatic 2
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Clinical Trial Locations for Ravicti

Trials by Country

Trials by Country for Ravicti
Location Trials
United States 47
Spain 3
Canada 2
Italy 2
Belgium 1
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Trials by US State

Trials by US State for Ravicti
Location Trials
Pennsylvania 5
New York 4
Ohio 4
Maine 3
California 3
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Clinical Trial Progress for Ravicti

Clinical Trial Phase

Clinical Trial Phase for Ravicti
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Ravicti
Clinical Trial Phase Trials
Completed 4
Recruiting 3
No longer available 2
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Clinical Trial Sponsors for Ravicti

Sponsor Name

Sponsor Name for Ravicti
Sponsor Trials
Horizon Therapeutics, LLC 3
Horizon Pharma Ireland, Ltd., Dublin Ireland 3
University of Pittsburgh 3
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Sponsor Type

Sponsor Type for Ravicti
Sponsor Trials
Other 12
Industry 6
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