Multicenter, Randomized Phase 2B Study Evaluating Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Cirrhotic Patients With Associated Hyperammonemia and an Episode of Hepatic Encephalopathy STOP-HE Study

Trial Profile

Multicenter, Randomized Phase 2B Study Evaluating Efficacy, Safety and Tolerability of OCR-002 (Ornithine Phenylacetate) in Hospitalized Cirrhotic Patients With Associated Hyperammonemia and an Episode of Hepatic Encephalopathy STOP-HE Study

Completed
Phase of Trial: Phase II

Latest Information Update: 23 Aug 2017

At a glance

  • Drugs Ornithine phenylacetate (Primary)
  • Indications Hepatic encephalopathy; Liver cirrhosis
  • Focus Therapeutic Use
  • Acronyms STOP-HE
  • Sponsors Ocera Therapeutics
  • Most Recent Events

    • 23 Aug 2017 According to an Ocera Therapeutics media release,data from this trial will be presented at the 68th Annual Meeting of the American Association for the Study of Liver Disease (AASLD).
    • 09 May 2017 According to an Ocera Therapeutics media release, the company reported new post-hoc analysis data from this trial.
    • 10 Mar 2017 Company is planning to meet with US FDA in Q3 2017 regarding this trial, according to an Ocera Therapeutics media release.
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