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A Multicenter, Open-Label Study to Evaluate ARC-520 Administered Alone and in Combination With Other Therapeutics in Patients With Chronic Hepatitis B Virus (HBV) Infection (MONARCH)

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Trial Profile

A Multicenter, Open-Label Study to Evaluate ARC-520 Administered Alone and in Combination With Other Therapeutics in Patients With Chronic Hepatitis B Virus (HBV) Infection (MONARCH)

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs ARC 520 (Primary) ; Entecavir; Peginterferon alfa-2a; Tenofovir dipivoxil fumarate
  • Indications Hepatitis B
  • Focus Therapeutic Use
  • Acronyms MONARCH
  • Sponsors Arrowhead Pharmaceuticals

    • Most Recent Events

    • 29 Nov 2016 Arrowhead Pharmaceuticals discontinued the development of ARC-520 based upon the discussion with the regulatory agencies regarding the substantial delays in all clinical programs that utilize EX1 and secondly, company has made substantial advances in RNA chemistry and targeting resulting in large potency gains for subQ administered and extra-hepatic RNAi-based development programs. Patients recruitment has been halted and dosing discontinued.
    • 29 Nov 2016 Status changed from recruiting to discontinued, as per an Arrowhead Pharmaceuticals media release.
    • 06 Oct 2016 According to an agreement between Arrowhead and Spring Bank, companies plan to study ARC-520, SB 9200, and an oral direct-acting antiviral in a cohort to be added in this trial, as reported by a company media release.

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