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Prospective Phase 3 Multi-center 2-Year Placebo Controlled Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation 80 Mg/Day in Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation Followed by a 2-Year Open Label Extension

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Trial Profile

Prospective Phase 3 Multi-center 2-Year Placebo Controlled Double Blind Study to Evaluate the Efficacy and Safety of Kamada-AAT for Inhalation 80 Mg/Day in Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation Followed by a 2-Year Open Label Extension

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 22 Jan 2025

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At a glance

  • Drugs Alpha 1-antitrypsin (Primary) ; Alpha 1-antitrypsin
  • Indications Alpha 1-antitrypsin deficiency
  • Focus Registrational; Therapeutic Use
  • Acronyms InnovAATe
  • Sponsors Kamada

Most Recent Events

  • 17 Jan 2025 Planned End Date changed from 1 Sep 2027 to 1 Jun 2031.
  • 17 Jan 2025 Planned primary completion date changed from 1 Mar 2027 to 1 Dec 2028.
  • 08 Jan 2025 According to a Kamada media release, Planned number of patients changed from 250 to 180.

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