Individual Patient Compassionate Use of Fedratinib
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03723148|
Expanded Access Status : Available
First Posted : October 29, 2018
Last Update Posted : September 18, 2020
- Study Details
- Tabular View
- How to Read a Study Record
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.
|Condition or disease||Intervention/treatment|
|Myelofibrosis||Drug: Oral Fedratinib|
|Study Type :||Expanded Access|
|Expanded Access Type :||Individual Patients|
|See clinical trials of the intervention/treatment in this expanded access record.|
|Official Title:||Compassionate Use of Fedratinib for Patients Who Have Previously Received TG101348, SAR302503 or Fedratinib|
- Drug: Oral Fedratinib
Oral fedratinib administered as directed by treating physician.Other Name: FEDR
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
Subjects will be considered if they received TG101348, SAR302503 or Fedratinib as a participant on a clinical trial prior to 31 Jan 2018.
Subject is eligible for enrollment in an ongoing clinical trial using Fedratinib or has been treated with Fedratinib after 31 Jan 2018.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03723148
|Contact: Celgene Medical Informationfirstname.lastname@example.org|
|United States, New Jersey|
|Summit, New Jersey, United States, 07901|
|Other Study ID Numbers:||
|First Posted:||October 29, 2018 Key Record Dates|
|Last Update Posted:||September 18, 2020|
|Last Verified:||September 2020|
Bone Marrow Diseases