NCT03723148

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 25, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 29, 2018

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

First QC Date

October 25, 2018

Last Update Submit

September 17, 2020

Conditions

Keywords

Expanded AccessCompassionate Use

Interventions

Oral fedratinib administered as directed by treating physician.

Also known as: FEDR

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects will be considered if they received TG101348, SAR302503 or Fedratinib as a participant on a clinical trial prior to 31 Jan 2018.

You may not qualify if:

  • Subject is eligible for enrollment in an ongoing clinical trial using Fedratinib or has been treated with Fedratinib after 31 Jan 2018.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celgene

Summit, New Jersey, 07901, United States

AVAILABLE

MeSH Terms

Conditions

Primary Myelofibrosis

Interventions

fedratinib

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Celgene Medical Information

CONTACT

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2018

First Posted

October 29, 2018

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations