- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06025227
Provide Pre-approval Single Patient Expanded Access (Compassionate Use) of Etrasimod for Patients.
November 8, 2023 updated by: Pfizer
Provide pre-approval single patient Expanded Access (Compassionate Use) of Etrasimod for patients.
Study Overview
Detailed Description
In Expanded Access, treating physicians are the Sponsors.
Expanded Access requests from treating physicians may be submitted to www.pfizercares.com.
Availability will depend on location and country.
Study Type
Expanded Access
Expanded Access Type
- Individual Patients
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
- Name: PfizerCares
- Email: PfizerCares@Pfizer.com
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
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Description
Patient must be intolerant, have a contraindication or had inadequate response to at least 3 therapies available for Ulcerative Colitis (UC) in this country or provide a rationale of why therapy was not used.
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?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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 Registration Dates
First Submitted
August 29, 2023
First Submitted That Met QC Criteria
August 29, 2023
First Posted (Actual)
September 6, 2023
Study Record Updates
Last Update Posted (Actual)
November 13, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C504
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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