Status:
COMPLETED
AOP2014 vs. BAT in Patients With Polycythemia Vera Who Previously Participated in the PROUD-PV Study.
Lead Sponsor:
AOP Orphan Pharmaceuticals AG
Collaborating Sponsors:
PharmaEssentia Corporation (for the U.S.)
Conditions:
Polycythemia Vera
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Polycythemia Vera (PV) is a disease of bone marrow stem cells that manifests in a drastic increase of red blood cells and frequently also of white blood cells. The "thickening" of the blood in relatio...
Detailed Description
This is a Phase III, parallel-arm, open-label continuation of the PROUD-PV study performed in adults diagnosed with Polycythemia Vera (PV). Patients who received AOP2014 in the primary study, PROUD-PV...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Patients who completed the 12 months AOP2014 treatment arm of the PROUD-PV study and at the "end-of-treatment visit" (EoT) of the PROUD-PV study who fulfill at least one of the following criteria:
- normalization of at least two out of three main blood parameters (Hct, PLTs and WBCs) if these parameters were moderately increased (Hct\<50%, WBC\<20 x 109/L, PLTs\<600 x 109/L) at baseline of the PROUD-PV study, OR
- \>35% decrease of at least two out of three main blood parameters (Hct, PLTs and WBCs) if these parameters were massively increased (Hct\>50%, WBCs\>20 x 109/L, PLTs\>600 x 109/L), at baseline of the PROUD-PV study, OR
- normalization of spleen size, if spleen was enlarged at baseline of the PROUD-PV study, OR
- otherwise a clear, medically verified benefit from treatment with AOP2014 (e.g. normalization of disease-related micro-vasculatory symptoms, substantial decrease of JAK2 allelic burden).
- Signed written ICF.
- Exclusion criteria:
- Withdrawal criteria, as specified in the PROUD-PV study, which mandate treatment discontinuation:
- Non-recovery from the AOP2014 related toxicities to the grade (usually, Grade I) which allows continuation of the treatment.
- HADS score of 11 or higher on either or both of the subscales, and /or development or worsening of the clinically significant depression or suicidal thoughts.
- Progressive and clinically significant increase of liver enzyme levels despite dose reduction, or if such increase is accompanied by increased bilirubin level, any signs or symptoms of a clinically significant autoimmune disease.
- Clinically significant development of a new ophthalmologic disorder, or worsening of a pre-existing one, during the study.
- Loss of efficacy of AOP2014 or any comparable situation where no further benefits of treatment continuation are expected by the investigator.
- The main efficacy evaluation criterion will be disease response defined as Hct\<45% without phlebotomy (at least 3 months since the last phlebotomy), PLTs\<400 x 109/L, WBCs\<10 x 109/L, and normal spleen size.
- The main efficacy endpoint will be the maintenance rate of disease response at assessment visits (every three months).
Exclusion
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 29 2021
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT02218047
Start Date
November 1 2014
End Date
April 29 2021
Last Update
June 1 2021
Active Locations (47)
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1
LKH Graz
Graz, Austria
2
University Hospital Innsbruck
Innsbruck, Austria
3
Elisabethinen Hospital Linz
Linz, Austria
4
Salzburg Regional Hospital
Salzburg, Austria