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Randomized Double-Blind Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B Virologically Suppressed for at Least Twelve Months on Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide or Entecavir

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Trial Profile

Randomized Double-Blind Study of Nitazoxanide Compared to Placebo in Subjects With HBeAG-Negative Chronic Hepatitis B Virologically Suppressed for at Least Twelve Months on Tenofovir Disoproxil Fumarate, Tenofovir Alafenamide or Entecavir

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 09 Nov 2023

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At a glance

  • Drugs Nitazoxanide (Primary) ; Entecavir; Tenofovir alafenamide; Tenofovir disoproxil fumarate
  • Indications Hepatitis B
  • Focus Pharmacodynamics
  • Sponsors Romark Laboratories

    • Most Recent Events

    • 03 Nov 2023 Status changed from active, no longer recruiting to completed.
    • 26 Jun 2022 Primary endpoint (mean change in quantitative Hepatitis B surface antigen (qHBsAg) from baseline to week 48) has not been met, as per results presented at The International Liver Congress 2022.
    • 26 Jun 2022 Results (n=48) assessing efficacy and safety of nitazoxanide for virologically suppressed HBeAg negative chronic Hepatitis B, presented at The International Liver Congress 2022.

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