Status:
COMPLETED
Ruxolitinib for Polycythemia Vera in Patients Resistant to or Intolerant of Hydroxyurea.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Polycythemia Vera (PV)
Eligibility:
All Genders
18-99 years
Brief Summary
This was an analytical and descriptive, non-interventional, retrospective cohort study of PV patients aged ≥ 18 years in the US using a secondary data source, Optum EHR database.
Detailed Description
The Optum EHR database was current up to 30-Jun-2020. Identification period: From 01-Apr-2007 to 30-Jun-2019 Study period: From 01-Jan-2007 to 30-Jun-2020 Index date: First evidence of resistance ...
Eligibility Criteria
Inclusion
- Included patients:
- With at least one International Classification of Diseases, 9th Revision, Clinical Modification/International Classification of Diseases,10th Revision, Clinical Modification code for PV in the identification period (01-Apr-2007 until 30-Jun-2019) that had non-missing sex and year of birth data and who were treated as part of the Integrated Delivery Network
- That were ≥ 18 years old at PV diagnosis
- With ≥ 2 prescriptions of HU
- That were classified as resistant to or intolerant of HU after a minimum of 3 months HU treatment (index date), defined as:
- HCT ≥ 45% with phlebotomy (last phlebotomy within last 3 months) or Platelet count \> 400 x 109/L and presence of palpable splenomegaly (palpable spleen up to 3 months after platelet count).
- To identify patients in the RUX group:
- \- With ≥ 2 prescriptions of RUX in the post-index period.
Exclusion
- Excluded patients:
- \- With a MF or AML diagnosis prior to a PV diagnosis.
Key Trial Info
Start Date :
November 27 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 29 2021
Estimated Enrollment :
1576 Patients enrolled
Trial Details
Trial ID
NCT05421104
Start Date
November 27 2020
End Date
June 29 2021
Last Update
July 5 2022
Active Locations (1)
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1
Novartis Investigative Site
East Hanover, New Jersey, United States, 07936-1080