Ruxolitinib for Chuvash Polycythemia
|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: NCT01730755|
Recruitment Status : Available
First Posted : November 21, 2012
Last Update Posted : January 8, 2016
|Condition or disease||Intervention/treatment|
|Erythrocytosis, Familial, 2||Drug: Ruxolitinib|
Study involvement will last for 48 weeks. There will be approximately 11 visits through week 48. Visits may take up to 2-3 hours to complete and occur every 4 weeks for the first 24 weeks, then every 12 weeks until week 48.
During each study visit, any or all of the following procedures may occur:
- List current medications and participant general health
- Obtain blood pressure, body weight, body temperature, respiratory rate and heart rate
- Measure Spleen by examination
- Obtain an abdominal MRI to evaluate spleen and any pre-existing or new blood clots
- Obtain blood samples for safety tests and to monitor kidney/liver function.
- Questionnaires for participant to complete regarding symptoms related to disease.
- Ruxolitinib dosing may be increased after 4 weeks if needed. The dose of the ruxolitinib may be reduced related to side effects.
|Study Type :||Expanded Access|
|Official Title:||Ruxolitinib for Chuvash Polycythemia|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01730755
|Contact: Karyn Gordon, BSNfirstname.lastname@example.org|
|Contact: Jennifer Riggsemail@example.com|
|United States, Missouri|
|Washington University School of Medicine|
|St. Louis, Missouri, United States, 63110|
|Contact: Karyn Gordon, BSN 314-362-0156 firstname.lastname@example.org|
|Principal Investigator: Stephen Oh, MD, PhD|