Polycythemia VeraPhase 3NCT05481151
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
A Phase 3 study testing P1101 (Ropeginterferon alfa-2b-njft) and Ropeginterferon alfa-2b-njft (P1101) in people with Polycythemia Vera, run by PharmaEssentia at 23 sites in 2 countries.
Trial summary
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Polycythemia Vera
- What is being tested?
- P1101 (Ropeginterferon alfa-2b-njft) and Ropeginterferon alfa-2b-njft (P1101)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 26 Oct 2022to 31 Jul 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects aged ≥18 years at the time of signing the informed consent form
- Subjects diagnosed with PV according to the 2008 or 2016 World Health Organization (WHO) criteria
- Subjects with good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin >3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN
- Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening
- Neutrophil count ≥1.5 × 10^9/L at screening
- Creatinine clearance rate ≥40 mL/min at screening (according to the Cockcroft-Gault formula)
- Males and 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, and females must agree to not breastfeed during the study
- Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study
Who cannot join
- Any contraindications to interferon alfa or hypersensitivity to interferon alfa
- Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
- Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
- History of major organ transplantation
- Pregnant or breastfeeding women
- Subjects with any other diseases that the Investigator determines will affect the study results or may weaken the compliance to protocol, including but not limited to:
Show all 21Show fewer
- Prior or current autoimmune thyroid disease (clinical symptoms of hyper- or hypo-thyroidism), except subjects with controlled thyroid replacement therapy, could be enrolled
- Other documented autoimmune diseases (such as hepatitis, immune thrombocytopenia [ITP], scleroderma, psoriasis, or any autoimmune arthritis)
- Clinically significant pulmonary infiltration, infectious pneumonia, and non-infectious pneumonia, or a past history of interstitial pneumonia at screening
- Active infection with systemic manifestations (e.g., presence of bacteria, fungi, and/or human immunodeficiency virus [HIV] at screening, excluding hepatitis B [HBV] and/or hepatitis C [HCV] at screening)
- Evidence of severe retinopathy (e.g., cytomegalovirus [CMV]-induced retinitis, macular degeneration) or clinically significant eye diseases (due to diabetes or hypertension)
- History or presence of clinically relevant depression per Investigator's judgment
- Previously had suicidal attempts or has any risk for suicidal tendency at screening
- Poorly controlled diabetes defined as HbA1c >8.0% for at least 1 year
- Active thromboembolic complications caused by PV and abdominal hemorrhage in the active phase
- History of any malignancy within 5 years (except adequately treated non-melanoma skin cancer, prostate cancer status post resection with an undetectable prostate-specific antigen (PSA), curative treated in-situ cancer of the cervix, ductal carcinoma in situ (DCIS) of the breast, Stage 1 Grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥2 years prior to study)
- History of alcohol or drug abuse in the past year
- History or evidence of post-polycythemia vera-myelofibrosis (PPV-MF), essential thrombocythemia, or any non-PV MPN
- Presence of blast cells in the peripheral blood in the past 12 weeks
- Use any investigational drug <4 weeks prior to the first dose of study drug, or not recovered from effects of prior administration of any investigational drug
- Any subject requiring a legally authorized representative
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States17 sites
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
Bethesda, Maryland, 20817
University of North Carolina Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27599
University of Virginia - Emily Couric Cancer Center
Charlottesville, Virginia, 22903
Astera HealthCare
East Brunswick, New Jersey, 08816
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46804
East Carolina University
Greenville, North Carolina, 27834
Wake Forest Baptist Medical Center
High Point, North Carolina, 27265
MD Anderson
Houston, Texas, 77030
Baptist MD Anderson
Jacksonville, Florida, 32207
University of Tennessee Health Science Center
Memphis, Tennessee, 38103
Tulane University Medical Center
New Orleans, Louisiana, 70112
Mount Sinai
New York, New York, 10029
Mercy Health
Paducah, Kentucky, 42003
University of Utah
Salt Lake City, Utah, 841312
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10467
University of Kansas Medical Center
Westwood, Kansas, 66205
Canada6 sites
Tom Baker Cancer Centre
Calgary, Alberta
Juravinski Cancer Center - Hamilton Health Sciences
Hamilton, Ontario
The Ottawa Hospital
Ottawa, Ontario, K1H 8L6
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Princess Margaret Hospital
Toronto, Ontario
St. Paul's Hospital
Vancouver, British Columbia
About this study
Official title: A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
Read the detailed description
Polycythemia vera (PV) is the most common type of chronic myeloproliferative neoplasm (MPN), with an annual reported incidence of up to 2.6/100,000. This is a long-term debilitating and life-threatening disease because it is associated with the risk of thrombosis, bleeding, and progression to myelofibrosis (MF) and secondary acute myeloid leukemia (sAML)
Ropeginterferon alfa-2b-njft (P1101), which gained US marketing authorization in November 2021, is the only interferon alfa approved for the treatment of PV.
This study aims to evaluate the efficacy, tolerability, and safety of ropeginterferon alfa-2b-njft (P1101) in US and Canadian PV patients, utilizing an optimized dosing regimen.
- Conditions
- Polycythemia Vera
- Being tested
- P1101 (Ropeginterferon alfa-2b-njft), Ropeginterferon alfa-2b-njft (P1101)
- Keywords
- Polycythemia Vera, Essential Thrombocythemia, P1101, Ropeginterferonalfa-2b-njft, Polycythemia, Vera, PharmaEssentia, Besremi, Ropeg
- Medical subject headings
- Polycythemia Vera, Thrombocythemia, Essential, Polycythemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1101 (Ropeginterferon alfa-2b-njft)Drug
Ropeginterferon alfa-2b-njft
Ropeginterferon alfa-2b-njft (P1101)Drug
Ropeginterferon alfa-2b-njft
| Study group | Role | What they receive |
|---|---|---|
| P1101 250-350-500mcg | Experimental | Pre-filled Syringe, Q2W starting at 250-350-500, SC injection Receives: Drug: P1101 (Ropeginterferon alfa-2b-njft) |
| Ropeginterferon alfa-2b-njft | Active comparator | Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection Receives: Drug: Ropeginterferon alfa-2b-njft (P1101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare efficacy, safety, and tolerability of P1101 utilizing 250-350-500 mcg compared to the current labeled dosing through assessing the proportion of subjects that are in a complete hematologic response at Week 24.
CHR is defined as hematocrit (HCT) <45%, white blood cell (WBC) count <10 × 10^9/L, platelets (PLT) ≤400 × 10^9/L in the absence of phlebotomy in the previous 12 weeks.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2022
- Study start26 Oct 2022
- Primary completion30 Jun 2025
- Study completion31 Jul 2027 (estimated)
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEssentia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ole Zagrijtschuk, MD, PhD, Study director, PharmaEssentia Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05481151
- Sponsor's protocol ID
- ECLIPSE PV / A22-203
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2022
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)
- ClinicalTrials.gov ID
- NCT05481151
- Acronym / sponsor ID
- ECLIPSE PV / A22-203
- Conditions
- Polycythemia Vera
- Keywords
- Polycythemia Vera, Essential Thrombocythemia, P1101, Ropeginterferonalfa-2b-njft, Polycythemia, Vera, PharmaEssentia, Besremi
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 111 participants (actual)
- Lead sponsor
- PharmaEssentiaIndustry (pharma, biotech, devices)
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 1 Aug 2022 (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.
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients with PV
Detailed description
Polycythemia vera (PV) is the most common type of chronic myeloproliferative neoplasm (MPN), with an annual reported incidence of up to 2.6/100,000. This is a long-term debilitating and life-threatening disease because it is associated with the risk of thrombosis, bleeding, and progression to myelofibrosis (MF) and secondary acute myeloid leukemia (sAML)
Ropeginterferon alfa-2b-njft (P1101), which gained US marketing authorization in November 2021, is the only interferon alfa approved for the treatment of PV.
This study aims to evaluate the efficacy, tolerability, and safety of ropeginterferon alfa-2b-njft (P1101) in US and Canadian PV patients, utilizing an optimized dosing regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P1101 250-350-500mcg | Experimental | Drug: P1101 (Ropeginterferon alfa-2b-njft)Pre-filled Syringe, Q2W starting at 250-350-500, SC injection |
| Ropeginterferon alfa-2b-njft | Active comparator | Drug: Ropeginterferon alfa-2b-njft (P1101)Pre-filled Syringe, Q2W starting at 100 up to 500 (50mcg increases), SC injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects aged ≥18 years at the time of signing the informed consent form
- Subjects diagnosed with PV according to the 2008 or 2016 World Health Organization (WHO) criteria
- Subjects with good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin >3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN
- Hemoglobin (HGB) ≥10 g/dL for females, and HGB ≥11 g/dL for males at screening
- Neutrophil count ≥1.5 × 10^9/L at screening
Key exclusion criteria (21 listed)
- Any contraindications to interferon alfa or hypersensitivity to interferon alfa
- Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
- Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
- History of major organ transplantation
- Pregnant or breastfeeding women
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 |
|---|---|---|
| P1101 (Ropeginterferon alfa-2b-njft)Ropeginterferon alfa-2b-njft | Drug | P1101 250-350-500mcg |
| Ropeginterferon alfa-2b-njft (P1101)Ropeginterferon alfa-2b-njft | Drug | Ropeginterferon alfa-2b-njft |
Primary outcome
Compare efficacy, safety, and tolerability of P1101 utilizing 250-350-500 mcg compared to the current labeled dosing through assessing the proportion of subjects that are in a complete hematologic response at Week 24.
Time frame: 24 weeks
CHR is defined as hematocrit (HCT) <45%, white blood cell (WBC) count <10 × 10^9/L, platelets (PLT) ≤400 × 10^9/L in the absence of phlebotomy in the previous 12 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Polycythemia Vera
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
RecruitingPhase 2/3
A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025).
Polycythemia Vera
RecruitingPhase 2
Study of Momelotinib in Combination With Luspatercept in Participants With Transfusion Dependent Myelofibrosis
Primary Myelofibrosis, Myelofibrosis; Primary Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis
RecruitingPhase 2
A Study of Ropeg-Interferon in People With Polycythemia Vera
Polycythemia Vera (PV), JAK2 Mutation
Active, not recruitingPhase 2
A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Polycythemia Vera (PV)
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.
Ole Zagrijtschuk, MD, PhD study director
PharmaEssentia Corporation
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing P1101 (Ropeginterferon alfa-2b-njft) and Ropeginterferon alfa-2b-njft (P1101) in people with Polycythemia Vera, run by PharmaEssentia at 23 sites in 2 countries.
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 8 inclusion and 21 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: under way, not looking for participants, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Compare efficacy, safety, and tolerability of P1101 utilizing 250-350-500 mcg compared to the current labeled dosing through assessing the proportion of subjects that are in a complete hematologic response at Week 24. (time frame: 24 weeks). 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 13 Aug 2025.