Status:
COMPLETED
Expanded Treatment Protocol (ETP) of Ruxolitinib in Patients With Polycythemia Vera Who Were Hydroxyurea Resistant or Intolerant and for Whom no Treatment Alternatives Was Available.
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Polycythemia Vera
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this open-label, single arm, multi-center Expanded Treatment Protocol (ETP) was to provide early access to ruxolitinib and evaluate safety information in patients with polycythemia vera...
Eligibility Criteria
Inclusion
- •Confirmed diagnosis of PV according to the 2008 World Health Organization criteria, palpable spleen, Resistant to or intolerant of hydroxyurea, ECOG performance status of 0, 1 or 2; did not have access to a comparable or satisfactory alternative treatment
Exclusion
- •Inadequate liver or renal function, Significant bacterial, fungal, parasitic, or viral infection requiring treatment, Active malignancy within the past 5 years, except treated cervical intraepithelial neoplasia, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin, with no evidence for recurrence in the past 3 years., Women who were pregnant or nursing.
Key Trial Info
Start Date :
November 21 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 29 2017
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT02292446
Start Date
November 21 2014
End Date
December 29 2017
Last Update
July 18 2019
Active Locations (65)
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1
Novartis Investigative Site
Linz, Austria, A-4010
2
Novartis Investigative Site
Salzburg, Austria, 5020
3
Novartis Investigative Site
Wels, Austria, A 4600
4
Novartis Investigative Site
Antwerp, Belgium, 2060