Either you have JavaScript disabled or your browser does not support Javascript . To work properly, this page requires JavaScript to be enabled.
How to enable JavaScript in your browser?

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

Next Previous
X
Search
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: 27 May 2024

Price : $35 *
  • Adis is an information provider.
  • Final gross price and currency may vary according to local VAT and billing address.
  • Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
  • A link to download a PDF version of the trial profile will be included in your email receipt.

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 May 2024 According to a Kamada media release, Following recent positive feedback from the U.S. Food and Drug Administration (FDA) through which the FDA expressed its willingness to potentially accept a P<0.1 alpha level in evaluating InnovAATe for meeting the efficacy primary endpoint for registration, we recently filed an IND amendment with both a revised Statistical Analysis Plan (SAP) and study protocol, and we expect further FDA feedback during the second half of 2024
    • 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
Subscriber content

You need to be a logged in subscriber to view this content.

If your organization has a subscription then there are several options available to help you access AdisInsight, even while working remotely.

  • IP authentication when working within your organization’s network.
  • with username/password or try via your institution
  • Persisted access using your organization’s identifier stored in your user browser for 90 days.
  • Contact us at AsktheExpert.AdisInsight@springer.com for assistance.

If your organization does not have a subscription to this content. To gain full access to the content and functionality of the AdisInsight database try one of the following.

  • Contact your organization’s admin about adding this content to your AdisInsight subscription
  • Buy a PDF version of the profile.
  • Request a free trial
Back to top