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An Open-label Phase 1/2 Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of RTX001 Autologous Macrophages in Participants With Liver Cirrhosis Who Have Hepatic Decompensation (EMERALD)

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Trial Profile

An Open-label Phase 1/2 Multicentre Study to Evaluate the Safety, Tolerability and Efficacy of RTX001 Autologous Macrophages in Participants With Liver Cirrhosis Who Have Hepatic Decompensation (EMERALD)

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 05 Jun 2025

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At a glance

  • Drugs RTX 001 Resolution Therapeutics (Primary)
  • Indications Liver cirrhosis
  • Focus Adverse reactions; First in man
  • Acronyms EMERALD
  • Sponsors Resolution Therapeutics

Most Recent Events

  • 12 Feb 2025 Planned number of patients changed to 30.
  • 19 Nov 2024 According to a Resolution Therapeutics media release, The EMERALD study received its first clinical trial authorisation from the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) earlier this year, and started recruiting patients in October 2024 in the U.K. It is expected to start recruiting patients in Spain in the second quarter of 2025.
  • 19 Nov 2024 According to a Resolution Therapeutics media release, the company has received the Approval of Clinical Trial Application by Spanish Agency of Medicines and Medical Products (AEMPS) to Expand Phase 1/2 EMERALD Study of RTX001 into Spain, following recent MHRA approval.

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