An observational study in Polycythemia Vera, sponsored by Novartis Pharmaceuticals. Completed at 51 sites in France. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Observational
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Among 12 studies in Polycythemia Vera by Novartis — none open to participants now, 2 under way, none of them phase 3. Polycythemia Vera · Novartis.
Among the 12 studies in Polycythemia Vera by Novartis, this one is the only one that started in 2025, is one of 4 observational ones, and was the 12th registered.
278 studies on the registry are indexed under Polycythemia Vera; 53 are open to participants now.
Browse Polycythemia Vera studies →None of the 12 studies in Polycythemia Vera by Novartis is open now. The open studies under Polycythemia Vera, anywhere →
Of the 42 Polycythemia Vera studies recruiting now, 38 (90%) set no upper age limit and 1 (2%) stops at 75 or younger; 4 take children under 18; 1 takes healthy volunteers.
This study: 18 Years to 99 Years · all sexes · no healthy volunteers.
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12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 1 · Phase 3 2 · Phase 4 2
First in 2013; this study’s year is marked. 1 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 237 is close to the median of 240 across 44 observational studies indexed under Polycythemia Vera.
Median enrollment 113 across the 6 interventional studies, 355 across the 4 observational. Of the 7 that completed or were terminated, 3 (43%) have results posted.
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This study is registered under Novartis Pharmaceuticals, one of the names counted as Novartis. Under that name alone:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
1 of the studies in Polycythemia Vera by Novartis that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05548062Novartis PharmaceuticalsStudy to Identify and Describe Predictive Factors for Thromboembolic Events in Patients With High-risk Polycythemia Vera | 2027-08-31 |
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Among the 12 studies in Polycythemia Vera by Novartis, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The aim of this study was to assess which cytoreductive treatments are currently administered in standard practice as second-line therapy to patients with polycythemia vera (PV) in France and to find out the reasons physicians switch treatments. In addition, the research aimed to describe real-world effectiveness of second-line cytoreductive therapies and the occurrence of adverse events of special interest.
Study data were collected from the medical charts of patients who initiated a second-line cytoreductive agent for the treatment of PV and received their first dose between 1 Jan 2022 and 31 Dec 2023.
Patients with PV who received a first dose of a second-line cytoreductive treatment between 1 January 2022 and 31 December 2023.
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Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adult PV patients who received a first dose of a second-line cytoreductive treatment between 1 January 2022 and 31 December 2023.
Proportion of Patients per Type of Second-line Cytoreductive Treatment
Time frame: Day 1 (first dose of second-line cytoreductive treatment)
Proportion of Patients per Type of First-line Cytoreductive Treatment
Time frame: Baseline
Proportion of Patients per Type of Third-line Cytoreductive Treatment
Time frame: Up to approximately 12 months
Initial Dose of Second-line Cytoreductive Treatment Received for Each Type of Treatment
Time frame: Day 1 (first dose of second-line cytoreductive treatment)
Duration of Each Line of Treatment
Time frame: Baseline up to approximately 12 months
Duration Between PV Diagnosis and Second-line Cytoreductive Treatment Initiation
Time frame: Baseline
Proportion of Patients With Treatment Interruptions and Dose Modification During Second-line Treatment
Time frame: Up to approximately 12 months
Proportion of Patients by Number of Dose Modifications During Second-line Cytoreductive Treatment
Dose modifications were categorized as an increase or decrease in dose.
Time frame: Up to approximately 12 months
Proportion of Patients Who Permanently Discontinued Second-line Cytoreductive Treatment
Time frame: Up to approximately 12 months
Proportion of Patients by Reasons for Switching to Second-line Cytoreductive Treatment
Time frame: Baseline
Proportion of Patients by Reasons for Switching to Third-line Cytoreductive Treatment
Time frame: Up to approximately 12 months
Proportion of Patients per Type of Concomitant Treatment/Procedure During Second-line Cytoreductive Treatment
Time frame: Up to approximately 12 months
Proportion of Patients Who had a Bone Marrow Biopsy Following PV Diagnosis and the Timing of Bone Marrow Biopsy in Relation to First-line Cytoreductive Treatment
Timing of bone marrow biopsy was categorized as: * Prior to first-line treatment * Prior to second-line treatment
Time frame: Baseline
Proportion of Patients Who had a Bone Marrow Biopsy Following PV Diagnosis and the Timing of Bone Marrow Biopsy in Relation to Second-line Cytoreductive Treatment
Timing of bone marrow biopsy was categorized as: * During second-line treatment * After second-line treatment
Time frame: Baseline
Proportion of Patients Achieving Hematocrit Control
Hematocrit control was defined as hematocrit \< 45% with the absence of phlebotomy eligibility during the last 3 months.
Time frame: Approximately 6 months
Proportion of Patients Achieving Clinicohematologic Response
Proportion of patients achieving clinicohematologic response according to the European LeukemiaNet (ELN) criteria (complete or partial). Complete clinicohematologic response was defined by: * Hematocrit \< 45% without phlebotomies during the last 3 months, and * Platelet count ≤ 400 x 10\^9/L, and * White blood cell count ≤ 10 x 10\^9/L, and * Normal spleen size evaluated by physical examination and/or by imaging. Partial clinicohematologic response was defined by: In patients who do not fulfill the criteria for complete response, hematocrit \< 45% without phlebotomy for 3 months OR response in 3 of the other criteria.
Time frame: Approximately 6 months
Proportion of Patients Achieving Symptom Response
Proportion of patients achieving symptom response according to the ELN criteria. Symptom response is defined as an absolute 10-point improvement in the Myeloproliferative Neoplasm Symptom Assessment Form - Total Symptom Score (MPN-SAF TSS). The MPN-SAF TSS (or MPN-10) is a validated patient-reported questionnaire that measures symptom burden in patients with myeloproliferative neoplasms. The instrument assesses 10 key disease-related symptoms, each scored from 0 (absent) to 10 (worst imaginable), generating a total score ranging from 0 to 100. Higher scores indicate greater symptom burden, and changes in the score are commonly used to evaluate clinical benefit and treatment response in both clinical practice and clinical trials
Time frame: Approximately 6 months
Proportion of Patients Achieving Molecular Response
Proportion of patients achieving molecular response according to the ELN criteria (complete or partial). Complete molecular response was defined by the reduction of any specific molecular abnormality to undetectable levels. Partial molecular response was defined by: * A reduction of ≥ 50% from baseline value in patients with \< 50% mutant allele burden at baseline OR * A reduction of ≥ 25% from baseline value in patients with ≥ 50% mutant allele burden at baseline.
Time frame: Approximately 6 months
Proportion of Patients With Occurrence of Disease Progression Events
Disease progression events include acute myeloid leukemia, myelofibrosis, and PV related death.
Time frame: Up to 6 approximately months
Proportion of Patients With Occurrence of Thromboembolic or Hemorrhagic Events
Thromboembolic and hemorrhagic events include arterial thrombotic, venous thrombotic, and hemorrhage.
Time frame: Up to 6 approximately months
Proportion of Patients by Sex
Time frame: Day 1 (first dose of second-line cytoreductive treatment)
Age
Time frame: Day 1 (first dose of second-line cytoreductive treatment)
Proportion of Patients With Cardiovascular and Thromboembolic Risk Factors
Time frame: Baseline
Proportion of Patients With a History of Medical Conditions
Medical conditions include cancer, autoimmune disease, and opportunistic infection.
Time frame: Baseline
Proportion of Patients With Other Ongoing Comorbidities
Time frame: Baseline
Proportion of Patients per Number and Type of Thromboembolic and Hemorrhagic Events Prior to First-line Treatment
Time frame: Baseline
Proportion of Patients per Number and Type of Thromboembolic and Hemorrhagic Events Between First- and Second-line Cytoreductive Treatment
Time frame: Baseline
Duration Between Most Recent Thromboembolic or Hemorrhagic Event and Initiation of First and Second-line Cytoreductive Treatment
Time frame: Baseline
Proportion of Patients by Reason for Initiating First-line Cytoreductive Treatment
Time frame: Baseline
Proportion of Patients per Type of Pre-specified Emergency Treatment/Procedure Administered Prior to Second-line Cytoreductive Treatment Initiation
Emergency treatments/procedures include antiplatelet drugs, anticoagulants, and phlebotomies.
Time frame: Baseline
Proportion of Patients by Number of Phlebotomies Required in the 3 Months Prior to Second-line Cytoreductive Treatment
Time frame: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)
Proportion of Patients by PV Symptoms
PV symptoms include splenomegaly, pruritus, fatigue, and bone pain.
Time frame: Day 1 (first dose of second-line cytoreductive treatment)
MPN-SAF TSS Score
The MPN-SAF TSS (or MPN-10) is a validated patient-reported questionnaire that measures symptom burden in patients with myeloproliferative neoplasms. The instrument assesses 10 key disease-related symptoms, each scored from 0 (absent) to 10 (worst imaginable), generating a total score ranging from 0 to 100. Higher scores indicate greater symptom burden, and changes in the score are commonly used to evaluate clinical benefit and treatment response in both clinical practice and clinical trials.
Time frame: Day 1 (first dose of second-line cytoreductive treatment)
Hemoglobin Level
Time frame: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)
Hematocrit Level
Time frame: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)
Leukocyte Count
Time frame: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)
Platelet Count
Time frame: Within the 3 months preceding Day 1 (first dose of second-line cytoreductive treatment)
Proportion of Patients by Type of Mutation
Time frame: Baseline
Mutant Allele Burden
Mutant allele burden is a molecular measure that quantifies the proportion of cells harboring a specific disease-associated mutation (e.g., JAK2 V617F, CALR, or MPL) within a patient sample. It is usually reported as the variant allele frequency (VAF), representing the percentage of mutant alleles among all alleles analyzed, and serves as an indicator of the size of the malignant clone in myeloproliferative neoplasms (MPNs). Changes in mutant allele burden may provide insight into the biological activity of the disease and the molecular effects of therapy. Mutant allele burden was categorized as ≥ 50% or \< 50%.
Time frame: Baseline
Proportion of Patients With Pre-specified Adverse Events of Special Interest Occurring After Initiation of the Second-line Cytoreductive Treatment
Pre-specified adverse events of special interest include thrombocytopenia, anemia, neutropenia, infection, weight gain, psychological disorders, nonmelanoma skin cancer, skin disorders, and autoimmune disorders.
Time frame: Up to 12 months
Plan to share: No
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Ran from Mar 2025 to primary completion in Oct 2025, 7 months.
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