Individual Patient Compassionate Use of Fedratinib

Celgene

Status

Conditions: Myelofibrosis

Treatments: Drug: Oral Fedratinib

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT03723148

FEDR

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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