A Phase 2, Fixed-Sequence, Open-Label, Switch-Over Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children 6-17 Years of Age With Urea Cycle Disorders, With a Long-Term Safety Extension

Trial Profile

A Phase 2, Fixed-Sequence, Open-Label, Switch-Over Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children 6-17 Years of Age With Urea Cycle Disorders, With a Long-Term Safety Extension

Completed
Phase of Trial: Phase II

Latest Information Update: 30 Nov 2015

At a glance

  • Drugs Glycerol phenylbutyrate (Primary)
  • Indications Hyperammonaemia
  • Focus Adverse reactions
  • Sponsors Hyperion Therapeutics
  • Most Recent Events

    • 30 Nov 2015 According to Horizon Pharma media release, the European Commission has approved glycerol phenylbutyrate oral liquid (RAVICTI) for treatment of urea cycle disorders in patients two months of age and older.
    • 27 Jun 2014 New trial record
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