Phase 1/2 Study of Intravenous or Intrapleural Administration of a Serotype rh.10 Replication Deficient Adeno-associated Virus Gene Transfer Vector Expressing the Human Alpha-1 Antitrypsin cDNA to Individuals With Alpha-1 Antitrypsin Deficiency

Trial Profile

Phase 1/2 Study of Intravenous or Intrapleural Administration of a Serotype rh.10 Replication Deficient Adeno-associated Virus Gene Transfer Vector Expressing the Human Alpha-1 Antitrypsin cDNA to Individuals With Alpha-1 Antitrypsin Deficiency

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 06 Mar 2018

At a glance

  • Drugs ADVM 043 (Primary) ; ADVM 043 (Primary)
  • Indications Alpha 1-antitrypsin deficiency
  • Focus Adverse reactions; First in man
  • Acronyms ADVANCE
  • Sponsors Adverum Biotechnologies
  • Most Recent Events

    • 26 Feb 2018 According to an Adverum Biotechnologies media release, the company announces completion of dosing of first cohort and based on a review of the preliminary safety data, the independent data monitoring committee (DMC) has recommended proceeding to the second cohort of patients, which is open for enrollment.
    • 28 Dec 2017 According to an Adverum Biotechnologies media release, the first patient has been dosed in this trial. Preliminary data expected in the second half of 2018.
    • 01 Dec 2017 Status changed from not yet recruiting to recruiting.
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