An observational study in Polycythemia Vera, sponsored by Novartis Pharmaceuticals. Completed at 99 sites in Germany. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2024-05-06.
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 one of 2 that started in 2015, is one of 4 observational ones, and was the 10th 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 120 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. 2 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 467 is above 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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Jakavi® therapy for polycythemia vera (PV) has so far been studied exclusively in clinical trials and at selected clinical trial centres. This observational study is intended to document the therapy of PV in daily practice with a broad patient population and a geographically representative selection of German centres (both hospitals and practices). The prospective mapping of daily practice reality is thus the main goal of this project.
To achieve meaningful results in accordance with the study objective and to obtain long-term data from daily clinical practice in a real-world setting, the observation period under Jakavi® therapy is specified as 36 months.
Adult male and female patients with PV for whom Jakavi® therapy is indicated.
Inclusion Criteria:
JAK inhibitor naive patients
Other: Jakavi
JAK inhibitor pre-treated patients (Jakavi® or any other JAK inhibitor for ≥3 months)
Other: Jakavi
Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.
Also known as: Ruxolitinib
Dosing
Number of patients by initial dosing and number of patients with dose modifications will be provided
Time frame: Up to 36 months
Treatment interruptions
Number of patients with treatment interruptions
Time frame: Up to 36 months
Overall survival
Overall survival for JAK inhibitor naive and pretreated patients
Time frame: Up to 36 months
Hematology
Number of patients with changes in different blood count values over time (hematocrit, erythrocytes, thrombocytes, leukocytes)
Time frame: Up to 36 months
Number of phlebotomies
Total number of phlebotomies
Time frame: Up to 36 months
Change in spleen size (or volume)
Measured by palpation/sonography/CT/MRI
Time frame: Up to 36 months
Quality of Life (QoL) - MPN-SAF TSS; MPN-10
The Myeloproliferative Neoplasm (MPN) Symptom Assessment Form Total Symptom Score (MPN-SAF TSS; MPN-10) questionnaire contains the ten most clinically relevant symptoms reported by patients with MPNs. It includes disease related symptoms each scored from 0 (absent) to 10 (worst imaginable). Total Scores range from 0-100, with higher scores indicating a greater number of symptoms and severity.
Time frame: Up to 36 months
Thromboembolic events
Number of patients with thromboembolic events.
Time frame: Up to 36 months
Eastern Cooperative Oncology Group (ECOG) performance status
The ECOG performance status is a scale used to assess how a patient's disease is progressing, assess how the disease affects the daily living abilities of the patient, and determine appropriate treatment and prognosis. The grade ranges from 0 (fully active, able to carry on all pre-disease performance without restriction) to 5 (dead)
Time frame: Up to 36 months
Change in constitutional symptoms
Number of patients with change in constitutional symptoms
Time frame: Up to 36 months
Quality of Life (QoL) - (SF-36)
The Short Form-36 questionnaire consists of questions measuring physical function, physical role limitation, pain, general health, vitality, social function, emotional role limitations, and mental health status. The scores that can be obtained from the scale vary between 0 and 100 and the increase in the scores indicates that the quality of life is high.
Time frame: Up to 36 months
Bone marrow aspiration and biopsy
Number of Biopsies per visit
Time frame: Up to 36 months
Molecular examination
Number of performed assessments of JAK2V617F mutation per visist
Time frame: Up to 36 months
Plan to share: No
Ran from Aug 2015 to primary completion in May 2023, 92 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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