A Randomised, Controlled, Open-Label Crossover Study of the Safety, Pharmacokinetics and Ammonia Control of RAVICTI (Glycerol Phenylbutyrate [GPB]) Oral Liquid and Sodium Phenylbutyrate (NaPBA) in Phenylbutyrate Treatment Naïve Patients with Urea Cycle Disorders (UCDs)

Trial Profile

A Randomised, Controlled, Open-Label Crossover Study of the Safety, Pharmacokinetics and Ammonia Control of RAVICTI (Glycerol Phenylbutyrate [GPB]) Oral Liquid and Sodium Phenylbutyrate (NaPBA) in Phenylbutyrate Treatment Naïve Patients with Urea Cycle Disorders (UCDs)

Recruiting
Phase of Trial: Phase III

Latest Information Update: 04 Oct 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
Restricted Access

Oops, it looks like you don’t have a valid subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • with a username/password associated to an account with a valid subscription
  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Request a trial

If you are a subscriber to this content then contact us at AsktheExpert.AdisInsight@springer.com so we can help.

Back to top