Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Are Available.
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|ClinicalTrials.gov Identifier: NCT02292446|
Recruitment Status : Completed
First Posted : November 17, 2014
Last Update Posted : October 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Polycythemia Vera||Drug: Ruxolitinib||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label, Multi-center, Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Are Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Are Available.|
|Actual Study Start Date :||November 21, 2014|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
All patients will receive ruxolitinib
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 0 to 39 months ]
- Change in hematocrit [ Time Frame: Up to 39 months ]Change in Hct levels from Baseline to each visit where measured
- Change in spleen [ Time Frame: Up to 39 months ]Change in spleen length from Baseline to each visit where measured.
- Change in MPN-SAF [ Time Frame: Up to 39 months ]Change in Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF) from baseline to each visit where measured.
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): NCT02292446
Show 65 Study Locations
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|