Polycythemia VeraPhase 4PVNCT06290765
Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera
A Phase 4 study testing Ropeginterferon alfa-2b and Phlebotomy and aspirin in people with Polycythemia Vera and Myeloproliferative Neoplasm, run by PharmaEssentia.
Trial summary
This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with PV. The entire study period is 60 weeks, including a main treatment phase (32 weeks), an extension treatment phase (24 weeks), and a safety follow-up phase (four weeks). Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Polycythemia Vera, Myeloproliferative Neoplasm
- What is being tested?
- Ropeginterferon alfa-2b and Phlebotomy and aspirin
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 30 Jun 2027
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 years at the time of informed consent (or other age required by local regulations);
- PV according to the World Health Organization (WHO) 2016 or 2022 Criteria;
- At least 3 phlebotomies within 24 weeks or at least 5 phlebotomies within 52 weeks prior to screening due to inadequate control of Hct value;
- Have the following hematological values immediately prior to randomization at baseline:
- Hematocrit <45%, and
- WBC ≥4× 109/L, and
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- Platelets ≥100 × 109/L;
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
- Patients receiving cytoreductive therapy must be on a stable dose or minimal dose adjustments for at least 24 weeks before screening and with no planned dose change;
- Patients who are not receiving cytoreductive therapy must have been discontinued from any prior cytoreductive therapy for at least 24 weeks before screening and have recovered from any adverse events;
- Females of childbearing potential, as well as all women < 2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug;
- Written informed consent obtained from the patient or the patient's legal representative, and ability for the patient to comply with the study requirements.
Who cannot join
- Patients requiring phlebotomy at Hct levels ˂45% according to Investigator judgement;
- Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) or PV-related bleeding within 2 months prior to randomization;
- Post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) (Tefferi et al 2013, Barosi et al 2008);
- Contraindication to pegylated interferon or its excipients;
- known resistance or intolerance to interferon based therapies, as judged by Investigator;
- Documented autoimmune disease (e.g., thyroid dysfunction, idiopathic thrombocytopenic purpura (ITP), scleroderma, psoriasis, or any arthritis of autoimmune origin). Patients with well-managed thyroid disease by oral hormonal replacement therapy could be enrolled;
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- Pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety or compliance with the protocol;
- Infections with systemic manifestations, e.g., bacterial, fungal, or human immunodeficiency virus (HIV), except inactive carriers of hepatitis B (HBV) and/or hepatitis C (HCV) at screening; inactive HBV carrier is defined as the presence of HBsAg and anti-Hepatitis B e-antigen (anti-HBe) antibody, HBV DNA ˂2000 IU/ml, and normal ALT (Invernizz et al 2016); inactive HCV carrier is defined as the presence of HCV RNA but has normal ALT or with no clinically significant symptom as judged by investigator;
- Any investigational drug less than 6 weeks prior to randomization or not recovered from the effects of prior administration of any investigational agent;
- History or presence of depression requiring treatment with antidepressant;
- Previous suicide attempts or at any risk of suicide at screening, in the judgement of the Investigator;
- Any significant morbidity or abnormality which may interfere with the study participation;
- Pregnant or lactating females;
- History of alcohol abuse or drug abuse within the last year;
- Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension);
- Significant liver (AST or ALT > 2.5 times ULN) or renal disease (creatinine > 2 mg/ml);
- History of major organ transplantation;
- History or presence of clinically significant neurologic diseases, e.g., uncontrolled severe seizure disorder;
- History of malignant disease, including solid tumors and hematological malignancies (except basal cell and squamous cell carcinomas of the skin and carcinoma in situ of the cervix that have been completely excised and are considered cured) within the last 3 years.
About this study
Official title: Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera - A Randomized Open Label Global Multicenter Study (PARADIGM-PV)
This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with PV. The entire study period is 60 weeks, including a main treatment phase (32 weeks), an extension treatment phase (24 weeks), and a safety follow-up phase (four weeks). However, the study may be extended for additional period of treatment after Week 60 pending the primary endpoint analysis at Week 32. Approximately 70 patients with PV will be enrolled.
- Conditions
- Polycythemia Vera, Myeloproliferative Neoplasm
- Being tested
- Ropeginterferon alfa-2b, Phlebotomy and aspirin
- Keywords
- PV, MPNs, Ropeginterferon alfa-2b, P1101, Hct, Phlebotomy, JAK2
- Medical subject headings
- Polycythemia Vera, Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropeginterferon alfa-2bDrug
Also called P1101
Ropeginterferon alfa-2b subcutaneously (SC) every two weeks (± 3 days), 250 µg at Day 1, 350 µg at Week 2, and target optimal dose of 500 µg at Week 4.
Phlebotomy should be conducted if confirmed Hct ≥48%, or confirmed Hct ≥45% that is ≥3% higher than baseline Hct value.
Phlebotomy and aspirinProcedure or surgery
Also called Phlebotomy and aspirin plus the other cytoreductive agents
Phlebotomy should be conducted if confirmed Hct ≥48%, or confirmed Hct ≥45% that is ≥3% higher than baseline Hct value, or confirmed Hct ≥45% according to the standard of care for phlebotomy at the institution regardless of the magnitude of the increase compared with the baseline. The same standard or criteria for phlebotomy eligibility should be applied for patients during the study at each study site or institution.
| Study group | Role | What they receive |
|---|---|---|
| Ropeginterferon alfa-2b group | Experimental | Ropeginterferon alfa-2b subcutaneously (SC) every two weeks (± 3 days), target optimal dose of 500 µg. Receives: Drug: Ropeginterferon alfa-2b; Procedure: Phlebotomy and aspirin |
| Control group | Other | Patients will continuously receive the same therapy as s/he received for PV indication prior to screening. Receives: Procedure: Phlebotomy and aspirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients whose Hct is maintained without phlebotomy eligibility from Week 20 through Week 32.
Phlebotomy eligibility is defined as either: a confirmed Hct ≥45% that is at least 3% higher than the baseline Hct, a confirmed Hct ≥48%, OR a confirmed Hct ≥45% according to the standard of care for phlebotomy at the institution regardless of the magnitude of the increase compared with the baseline.
Measured: From Week 20 through Week 32
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Aug 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Why it stopped: In alignment with company strategic direction.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycythemia VeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEssentia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290765
- Sponsor's protocol ID
- A23-401
- Acronym
- PV
- Status last verified
- Jul 2025
- First submitted
- 26 Jan 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera - A Randomized Open Label Global Multicenter Study (PARADIGM-PV)
- ClinicalTrials.gov ID
- NCT06290765
- Acronym / sponsor ID
- PV / A23-401
- Conditions
- Polycythemia Vera, Myeloproliferative Neoplasm
- Keywords
- PV, MPNs, Ropeginterferon alfa-2b, P1101, Hct, Phlebotomy, JAK2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: In alignment with company strategic direction.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- PharmaEssentiaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 4 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with PV. The entire study period is 60 weeks, including a main treatment phase (32 weeks), an extension treatment phase (24 weeks), and a safety follow-up phase (four weeks). However, the study may be extended for additional period of treatment after Week 60 pending the primary endpoint analysis at Week 32. Approximately 70 patients with PV will be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropeginterferon alfa-2b group | Experimental | Drug: Ropeginterferon alfa-2b, Procedure: Phlebotomy and aspirinRopeginterferon alfa-2b subcutaneously (SC) every two weeks (± 3 days), target optimal dose of 500 µg. |
| Control group | Other | Procedure: Phlebotomy and aspirinPatients will continuously receive the same therapy as s/he received for PV indication prior to screening. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Age ≥18 years at the time of informed consent (or other age required by local regulations);
- PV according to the World Health Organization (WHO) 2016 or 2022 Criteria;
- At least 3 phlebotomies within 24 weeks or at least 5 phlebotomies within 52 weeks prior to screening due to inadequate control of Hct value;
- Have the following hematological values immediately prior to randomization at baseline:
- Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2.
Key exclusion criteria (19 listed)
- Patients requiring phlebotomy at Hct levels ˂45% according to Investigator judgement;
- Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) or PV-related bleeding within 2 months prior to randomization;
- Post-PV myelofibrosis as defined by the International Working Group-Myeloproliferative Neoplasms Research and Treatment (IWG-MRT) (Tefferi et al 2013, Barosi et al 2008);
- Contraindication to pegylated interferon or its excipients;
- known resistance or intolerance to interferon based therapies, as judged by Investigator;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropeginterferon alfa-2bAlso: P1101Ropeginterferon alfa-2b subcutaneously (SC) every two weeks (± 3 days), 250 µg at Day 1, 350 µg at Week 2, and target optimal dose of 500 µg at Week 4. Phlebotomy should be conducted if confirmed Hct ≥48%, or confirmed Hct ≥45% that is ≥3% higher than baseline Hct value. | Drug | Ropeginterferon alfa-2b group |
| Phlebotomy and aspirinAlso: Phlebotomy and aspirin plus the other cytoreductive agentsPhlebotomy should be conducted if confirmed Hct ≥48%, or confirmed Hct ≥45% that is ≥3% higher than baseline Hct value, or confirmed Hct ≥45% according to the standard of care for phlebotomy at the institution regardless of the magnitude of the increase compared with the baseline. The same standard or criteria for phlebotomy eligibility should be applied for patients during the study at each study site or institution. | Procedure or surgery | Control group, Ropeginterferon alfa-2b group |
Primary outcome
The proportion of patients whose Hct is maintained without phlebotomy eligibility from Week 20 through Week 32.
Time frame: From Week 20 through Week 32
Phlebotomy eligibility is defined as either: a confirmed Hct ≥45% that is at least 3% higher than the baseline Hct, a confirmed Hct ≥48%, OR a confirmed Hct ≥45% according to the standard of care for phlebotomy at the institution regardless of the magnitude of the increase compared with the baseline.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropeginterferon alfa-2b and Phlebotomy and aspirin in people with Polycythemia Vera and Myeloproliferative Neoplasm, run by PharmaEssentia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients whose Hct is maintained without phlebotomy eligibility from Week 20 through Week 32. (time frame: From Week 20 through Week 32). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.