An open, prospective, single arm study investigating efficacy and safety of human hepatitis B immunoglobulin Zutectra in liver transplanted patients - the ZEUS Study

Trial Profile

An open, prospective, single arm study investigating efficacy and safety of human hepatitis B immunoglobulin Zutectra in liver transplanted patients - the ZEUS Study

Completed
Phase of Trial: Phase III

Latest Information Update: 12 May 2015

At a glance

  • Drugs Hepatitis B immune globulin (Primary)
  • Indications Hepatitis B
  • Focus Registrational; Therapeutic Use
  • Acronyms ZEUS
  • Sponsors Biotest AG
  • Most Recent Events

    • 23 Apr 2015 According to a Biotest media release, the dossier for "Zutectra-early-use" which will allow earliest conversion to subcutaneous administration of Zutectra at the earliest one week after liver transplantation has been submitted to the European Medicines Agency (EMA) for EU-Approval. The approval process is expected to be finalized in the fourth quarter of 2015.
    • 23 Apr 2015 According to a Biotest media release, the results from this trial were presented at the 50th International Liver Congress 2015.
    • 31 Mar 2015 Last checked against ClinicalTrials.gov record.
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