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A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection

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Trial Profile

A Phase 2a, Multicenter, Single-Blind, Placebo-Controlled, Multiple Cohort Study Evaluating ABI-H2158-Containing Regimens in Chronic Hepatitis B Infection

Status: Discontinued
Phase of Trial: Phase II

Latest Information Update: 16 Sep 2022

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At a glance

  • Drugs ABI-H2158 (Primary) ; Entecavir
  • Indications Hepatitis B
  • Focus Adverse reactions; Proof of concept; Therapeutic Use
  • Sponsors Assembly Biosciences

Most Recent Events

  • 17 Mar 2022 Status changed from active, no longer recruiting to discontinued due to a safety signal of drug-induced liver injury in subjects receiving 2158.
  • 08 Nov 2021 Status changed from discontinued to active, no longer recruiting.
  • 01 Sep 2021 According to an Assembly Biosciences media release, after communicating the company's decision to the FDA, the FDA noted that 2158 would also be placed on clinical hold. Company will focus on advancing ongoing triple combination studies and earlier pipeline candidates.

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