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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Rifaximin 550 mg BID For 6 Months In Preventing Hepatic Encephalopathy.

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Trial Profile

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Rifaximin 550 mg BID For 6 Months In Preventing Hepatic Encephalopathy.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Aug 2023

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At a glance

  • Drugs Rifaximin (Primary) ; Lactulose
  • Indications Hepatic encephalopathy
  • Focus Registrational; Therapeutic Use
  • Sponsors Bausch Health Companies; Salix Pharmaceuticals

    • Most Recent Events

    • 24 Jun 2023 Results of post hoc pooled analysis assessing the efficacy and safety of rifaximin plus lactulose versus lactulose alone in patients with cirrhosis, with or without diabetes from NCT00298038 and NCT01842581 trials, presented at the European Association for the Study of the Liver Congress 2023.
    • 08 Nov 2022 Results of post hoc, pooled analysis from NCT00298038 and NCT01842581; examining rifaximin plus lactulose versus lactulose alone for prevention ofOHE recurrence in patients with cirrhosis and historyof OHE, presented at The Liver Meeting 2022: 73rd Annual Meeting of the American Association for the Study of Liver Diseases
    • 27 Oct 2021 Results(N=139) of post-hoc subgroup analysis assessing rifaximin + lactulose (L) vs L alone for prevention of OHE recurrence in patients with a history of OHE, subgrouped by cirrhosis etiology presented at the American College of Gastroenterology Annual Scientific Meeting and Postgraduate Course 2021
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