Evusheld Japan PMS_Japan Post-Marketing Surveillance (PMS)

March 29, 2024 updated by: AstraZeneca

General Drug Use-Result Study of Evusheld Intramuscular Injection Set (Treatment and Prevention of Symptomatic Disease Caused by SARS-CoV-2 Infection)

To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.

Study Overview

Status

Recruiting

Conditions

Detailed Description

To investigate intends to evaluate the incidence of adverse drug reactions (ADRs) in individuals who receive Evusheld in clinical practice to determine its post-marketing safety profile in Japanese.

The investigation will be conducted as the addtional pharmacovigilance activitiy specified in the Japan Risk Management Plan (J-RMP) of Evusheld in compliance with the Ministerial Ordinance on Good Post-marketing Study Practice (GPSP Ordinance) and for the purpose of application for re-examination under Article 14-4 of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices (PMD Act).

Study Type

Observational

Enrollment (Estimated)

700

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Aichi, Japan
        • Active, not recruiting
        • Research Site
      • Aichi, Japan
        • Recruiting
        • Research Site
      • Chiba, Japan
        • Recruiting
        • Research Site
      • Fukuoka, Japan
        • Recruiting
        • Research Site
      • Fukuoka, Japan
        • Withdrawn
        • Research Site
      • Fukushima, Japan
        • Recruiting
        • Research Site
      • Gifu, Japan
        • Active, not recruiting
        • Research Site
      • Hiroshima, Japan
        • Active, not recruiting
        • Research Site
      • Hokkaido, Japan
        • Recruiting
        • Research Site
      • Hyogo, Japan
        • Recruiting
        • Research Site
      • Ibaraki, Japan
        • Recruiting
        • Research Site
      • Ishikawa, Japan
        • Recruiting
        • Research Site
      • Iwate, Japan
        • Active, not recruiting
        • Research Site
      • Kagoshima, Japan
        • Recruiting
        • Research Site
      • Kagoshima, Japan
        • Withdrawn
        • Research Site
      • Kanagawa, Japan
        • Active, not recruiting
        • Research Site
      • Kumamoto, Japan
        • Withdrawn
        • Research Site
      • Kyoto, Japan
        • Recruiting
        • Research Site
      • Kyoto, Japan
        • Completed
        • Research Site
      • Mie, Japan
        • Completed
        • Research Site
      • Nagasaki, Japan
        • Active, not recruiting
        • Research Site
      • Nara, Japan
        • Recruiting
        • Research Site
      • Nara, Japan
        • Active, not recruiting
        • Research Site
      • Niigata, Japan
        • Withdrawn
        • Research Site
      • Oita, Japan
        • Withdrawn
        • Research Site
      • Okayama, Japan
        • Active, not recruiting
        • Research Site
      • Okayama, Japan
        • Withdrawn
        • Research Site
      • Osaka, Japan
        • Active, not recruiting
        • Research Site
      • Osaka, Japan
        • Terminated
        • Research Site
      • Osaka, Japan
        • Recruiting
        • Research Site
      • Tokyo, Japan
        • Recruiting
        • Research Site
      • Tokyo, Japan
        • Active, not recruiting
        • Research Site
      • Tokyo, Japan
        • Withdrawn
        • Research Site
      • Tottori, Japan
        • Recruiting
        • Research Site
      • Yamanashi, Japan
        • Active, not recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Treatment and prevention of symptomatic disease caused by SARS-CoV-2 infection

Description

Inclusion Criteria:

  • For treatment of symptomatic disease caused by SARS-CoV-2 infection; Patients with risk factors for severe SARS-CoV-2 infection who do not require supplemental oxygen.
  • For prevention of symptomatic disease caused by SARS-CoV-2 infection; Individuals for whom SARS-CoV-2 vaccination is not recommended OR those who are considered to have an inadequate response to a COVID-19 vaccine due to immunodeficiencies AND who is not close contacts such as family members or other people living in the same dwelling as patients infected with SARS-CoV-2.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of ADRs
Time Frame: 24weeks(6 months)
The incidence of ADRs related to Evusheld Safety Specification; anaphylaxis and other serious allergic reactions, cardiovascular events
24weeks(6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Study Director: Toshimitsu Tokimoto, AstraZeneca KK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 6, 2023

Primary Completion (Estimated)

March 31, 2026

Study Completion (Estimated)

March 31, 2026

Study Registration Dates

First Submitted

December 16, 2022

First Submitted That Met QC Criteria

January 17, 2023

First Posted (Actual)

January 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 29, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D8850C00019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal.All request will be evaluated as per the AZ disclosure commitment.

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contact for data accessors ) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, Pleas review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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