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: 03 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

    • 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.
    • 08 Mar 2017 Results published in an Ocera Therapeutics media release.
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