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A Randomized Double Blind Active Comparator Controlled Phase III Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection

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Trial Profile

A Randomized Double Blind Active Comparator Controlled Phase III Study to Assess the Safety and Efficacy of RHB-105 in the Treatment of Confirmed Helicobacter Pylori (H. Pylori) Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2024

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At a glance

  • Drugs Amoxicillin/omeprazole/rifabutin (Primary) ; Amoxicillin; Omeprazole
  • Indications Helicobacter pylori infections
  • Focus Registrational; Therapeutic Use
  • Acronyms ERADICATE Hp 2
  • Sponsors RedHill Biopharma

    • Most Recent Events

    • 12 Mar 2024 According to a RedHill Biopharma media release,the company announced the issue of a new U.S. patent covering Talicia as an all-in-one fixed-dose combination of amoxicillin, omeprazole and rifabutin and its use for the treatment of helicobacter pylori (H. pylori) infection (Patent No. 11,931,463 to be issued March 19, 20244)
    • 01 Aug 2023 According to a RedHill Biopharma media release, Gaelan Medical received marketing approval from the United Arab Emirates (UAE) Ministry of Health for Talicia (omeprazole magnesium, amoxicillin and rifabutin).
    • 04 Nov 2022 Results of post hoc analysis of pooled, modified intention-to-treat data from 293 subjects in the Phase 3 trials (NCT01980095/ NCT03198507) presented at The Obesity Society: ObesityWeek 2022.
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