RAVICTI

DRUG4 trials

Sponsors

University of Pittsburgh, Robert Squires, Jr., Amgen

Conditions

Byler DiseaseMedium-chain Acyl-CoA Dehydrogenase (MCAD) DeficiencyUrea Cycle Disorder

Phase 1

Use of Ravicti™ in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation

CompletedNCT01881984

University of PittsburghMedium-chain Acyl-CoA Dehydrogenase (MCAD) Deficiency

Start: 2013-06-30End: 2016-02-29Updated: 2017-09-25

Phase 4

A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders

CompletedNCT02246218

AmgenUrea Cycle Disorder

Start: 2014-12-31End: 2017-07-17Updated: 2024-07-01

Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)

CompletedNCT03335488

AmgenUrea Cycle Disorder

Start: 2018-02-20End: 2022-12-20Updated: 2024-07-01

Unknown Phase

Expanded Access Protocol for an Intermediate Size Population - RAVICTI for Byler Disease

Robert Squires, Jr.Byler Disease

Updated: 2019-02-18