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
Status:
Completed
Phase of Trial:
Phase IV
Latest Information Update: 11 Mar 2024
Price :
$35
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At a glance
- Drugs Glycerol phenylbutyrate (Primary) ; Sodium phenylbutyrate
- Indications Hyperammonaemia; Inborn urea cycle disorders
- Focus Therapeutic Use
- Sponsors Horizon Pharma USA
- 01 Mar 2023 Status changed from recruiting to completed.
- 27 Jul 2020 This trial has been completed in United Kingdom according to European Clinical Trials Database record.
- 14 Feb 2020 Planned End Date changed from 31 Mar 2020 to 1 Mar 2023.