Individual Patient Compassionate Use of Fedratinib

Last updated: September 17, 2020
Sponsor: Celgene
Overall Status: Planned

Phase

N/A

Condition

Myelofibrosis

Post-polycythemia Vera Myelofibrosis

Treatment

N/A

Clinical Study ID

NCT03723148
FEDR
  • Ages > 18
  • All Genders

Study Summary

This is an expanded access program (EAP) for eligible participants designed to provide access to fedratinib.

Expanded access is only available in markets where fedratinib is not yet approved.

Eligibility Criteria

Inclusion

Inclusion Criteria: Subjects will be considered if they received TG101348, SAR302503 or Fedratinib as aparticipant on a clinical trial prior to 31 Jan 2018.

Exclusion

Exclusion Criteria: Subject is eligible for enrollment in an ongoing clinical trial using Fedratinib or hasbeen treated with Fedratinib after 31 Jan 2018.

Study Design

Study Start date:
Estimated Completion Date:

Study Description

This program is being offered on a patient by patient basis and will require company, Institutional Review Board/Independent Ethics Committee and Single Patient IND approval.

Connect with a study center

  • Celgene

    Summit, New Jersey 07901
    United States

    Planned

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