A Randomised, Controlled, Open-Label Parallel Arm Study of Safety, PK and Ammonia Control of RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid and Sodium Phenylbutyrate in Phenylbutyrate Treatment Naïve Patients With Urea Cycle Disorders

Trial Profile

A Randomised, Controlled, Open-Label Parallel Arm Study of Safety, PK and Ammonia Control of RAVICTI® (Glycerol Phenylbutyrate) Oral Liquid and Sodium Phenylbutyrate in Phenylbutyrate Treatment Naïve Patients With Urea Cycle Disorders

Recruiting
Phase of Trial: Phase IV

Latest Information Update: 11 Nov 2017

At a glance

  • Drugs Glycerol phenylbutyrate (Primary) ; Phenylbutyrates
  • Indications Hyperammonaemia
  • Focus Therapeutic Use
  • Sponsors Horizon Pharma USA
  • Most Recent Events

    • 29 Apr 2016 Planned End Date changed from 2 Apr 2018 to 18 May 2018.
    • 16 Dec 2015 New trial record
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