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Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients With Chronic Hepatitis Delta Virus (HDV) Infection (LIMT-2)

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Trial Profile

Phase 3, Randomized, Open-Label, Parallel Arm Study to Evaluate the Efficacy and Safety of 180 mcg Peginterferon Lambda-1a (Lambda) Subcutaneous Injection for 48 Weeks in Patients With Chronic Hepatitis Delta Virus (HDV) Infection (LIMT-2)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 25 Sep 2024

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At a glance

  • Drugs Peginterferon lambda-1a (Primary)
  • Indications Hepatitis D
  • Focus Registrational; Therapeutic Use
  • Acronyms LIMT-2
  • Sponsors Eiger BioPharmaceuticals, Inc.

Most Recent Events

  • 12 Sep 2023 According to an Eiger BioPharmaceuticals media release, company announced its decision to discontinue the Phase 3 LIMT-2 study, the decision is based on the recommendation of the Data Safety Monitoring Board (DSMB) for the study following its quarterly safety review. The review dated September 7, 2023, the DSMB recommended the discontinuation of the LIMT-2 study due to observations of four patients with hepatobiliary events that resulted in liver decompensation.
  • 12 Sep 2023 Status changed from active, no longer recruiting to discontinued, according to an Eiger BioPharmaceuticals media release.
  • 23 Aug 2023 Status changed from recruiting to active, no longer recruiting.

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