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A Prospective Phase III Multi-center, 2-Year Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of "Kamada-AAT for Inhalation" 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% ≤ FEV1 ≤ 80% of predicted; FEV1/SVC ≤ 70%), Followed by a 2-Year Open-Label Extension

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Trial Profile

A Prospective Phase III Multi-center, 2-Year Placebo Controlled, Double Blind Study to Evaluate the Efficacy and Safety of "Kamada-AAT for Inhalation" 80 mg per day in Adult Patients with Congenital Alpha-1 Antitrypsin Deficiency with Moderate and Severe Airflow Limitation (40% ≤ FEV1 ≤ 80% of predicted; FEV1/SVC ≤ 70%), Followed by a 2-Year Open-Label Extension

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 16 Apr 2024

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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

    • 07 Mar 2024 According to a Kamada media release,the company is planning to present a revised statistical analysis plan (SAP) and study protocol for the InnovAATe study and to seek the FDA feedback by mid-2024
    • 21 Sep 2023 Results assessing the impact of Dutch governmental NPI's on the COPD exacerbations and respiratory infections rate in patients with severe alpha-1 antitrypsin deficiency published in the COPD: Journal of Chronic Obstructive Pulmonary Disease
    • 16 Aug 2023 According to a Kamada media release, the company received positive scientific advice from the European Medicines Agency (EMA) that reconfirmed the overall design of study. Discussion with the FDA regarding study progress will be completed by the end of 2023.
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