Polycythemia Vera (PV)Phase 2NCT04182100
Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply
A Phase 2 study testing P1101, Low-dose aspirin and Phlebotomy in people with Polycythemia Vera (PV), run by PharmaEssentia Japan K.K. at 8 sites in Japan.
Trial summary
This is a Phase 2 single arm study to investigate efficacy and safety of P1101 for adult Japanese patients with PV. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Polycythemia Vera (PV)
- What is being tested?
- P1101, Low-dose aspirin and Phlebotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 8 sitesJapan
- Study dates
- 20 Dec 2019to 8 Mar 2021
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients ≥20 years old
- Patients diagnosed with PV according to the WHO 2008 or WHO 2016 criteria
- PV patients for whom the current standard of treatment is difficult to apply. (Patients with a documented history of refractory to HU are excluded.)
- Younger patients (long-term treatment is anticipated)
- Patients who are categorized as low risk, but cytoreduction is recommended due to disease-related signs and symptoms (headache, dizziness, pruritus, night sweats, fatigue, erythromelalgia, vision disorders, scintillating scotoma, early satiety, abdominal distension).
- Patients with HU intolerance
Show all 20Show fewer
- Total HU treatment duration shorter than 3 years (cumulatively) at screening
- For cytoreduction naïve patients only: PV in need of cytoreductive treatment, defined by fulfilling as one or more of the following criteria at baseline:
- at least one previous well documented major cardiovascular PV-related event in the medical history
- poor tolerance of phlebotomy (defined as a phlebotomy/ procedure-related adverse event causing significant adverse impact on the patient and limiting ability to apply phlebotomy with the intention to keep Hct <45%)
- frequent need of phlebotomy (more than one phlebotomy within last month prior entering the study)
- platelet counts greater than 1000 x 10^9/L (for two measurements within the month prior treatment start)
- leukocytosis (WBC>10 x 10^9/L for two measurements within the month prior treatment start)
- Adequate hepatic function defined as bilirubin ≤1.5 x upper limit normal (ULN), international normalized ratio (INR) ≤1.5 x ULN, albumin >3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 x ULN, aspartate aminotransferase (AST) ≤2.0 x ULN at screening
- Hemoglobin (HGB) ≥10 g/dL at screening
- Neutrophil count ≥1.5 x 10^9/L at screening
- Serum creatinine ≤1.5 x ULN at screening
- Hospital Anxiety and Depression Scale (HADS) score 0-7 on both subscales (Patients with a borderline of HADS score [score 7 but <10] or patients with necessity [expected benefits are higher than the risks] based on investigators' discretion are required to receive following assessment by psychiatric specialist to confirm the eligibility for IFNα therapy.).
- 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 28 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 requirements of the study
Who cannot join
- Patients with symptomatic splenomegaly
- Previous use of IFNα for any indication
- Any contraindications or hypersensitivity to interferon-alfa
- Co-morbidity with severe or serious conditions which may impact patient participation in the study in investigator's opinion
- History of major organ transplantation
- Pregnant or lactating females
Show all 20Show fewer
- Patients with any other medical conditions, which in the opinion of the Investigator would compromise the results of the study or may impair compliance with the requirements of the protocol
- 7-1. History or presence of thyroid dysfunction (clinical symptoms of hyper- or hypo-thyroidism) of the autoimmune origin, except late stages cases on the oral thyroid substitution therapy, where potential exacerbation under interferon therapy will not constitute any further harm to the patient
- 7-2.Documented autoimmune disease (e.g., hepatitis, idiopathic thrombocytopenic purpura [ITP], scleroderma, psoriasis, or any autoimmune arthritis)
- 7-3. Clinically relevant pulmonary infiltrates and pneumonitis at screening, patients with a history of interstitial pulmonary disease
- 7-4. Active infections with systemic manifestations (e.g., bacterial, fungal, hepatitis B [HBV], hepatitis C [HCV], or human immunodeficiency virus [HIV]) at screening)
- 7-5. Evidence of severe retinopathy (e.g., cytomegalovirus retinitis [CMV], macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension) based on the ophthalmological assessment by specialists.
- 7-6. Uncontrolled depression
- 7-7. Previous suicide attempts or at any risk of suicide at screening
- Uncontrolled diabetes mellitus (HbA1c level of > 7% at baseline)
- History of any malignancy within for the past 5 years
- History of alcohol or drug abuse within the last year
- History or evidence of post polycythemia vera-myelofibrosis (PPV-MF), essential thrombocythemia, or any non-PV MPN
- Presence of circulating blasts in the peripheral blood within the last 3 months
- Use of any investigational drug(s), or investigational drug combinations <4 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Japan8 sites
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
University of Yamanashi Hospital
Chuo-shi, Yamanashi, 409-3898
NTT Medical Center Tokyo
Shinagawa-ku, Tokyo, 141-8625
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023
Keio University Hospital
Shinjuku-ku, Tokyo, 160-8582
Osaka University Hospital
Suita-shi, Osaka, 565-0871
Ehime University Hospital
Toon-shi, Ehime, 791-0295
Mie University Hospital
Tsu, Mie-ken
About this study
Official title: Phase 2 Single Arm Study of Efficacy and Safety of P1101 for Polycythemia Vera (PV) Patients for Whom the Current Standard of Treatment is Difficult to Apply
This is a Phase 2 single arm study to investigate efficacy and safety of P1101 for adult Japanese patients with PV.
Read the detailed description
Eligible patients will be treated with P1101, starting at 100 μg (or 50 μg in patients under another cytoreductive therapy). The dose should be gradually increased by 50 μg every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilization of the hematological parameters is achieved (hematocrit <45%, platelets <400 x 10^9/L and leukocytes <10 x 10^9/L). The maximum recommended single dose is 500 μg injected every two weeks.
At week 36 (month 9) and week 52 (month 12), the primary study endpoint, phlebotomy-free CHR, will be analyzed. After completion of the 52-week study duration, provision and administration of P1101, collection of the long-term follow up information (blood parameters, molecular and cytogenetic data, safety parameters and as also the optional bone marrow data) will be continued until the drug becomes commercially available for all study subjects..
- Conditions
- Polycythemia Vera (PV)
- Being tested
- P1101, Low-dose aspirin, Phlebotomy
- Keywords
- Myeloproliferative Neoplasms
- 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.
P1101Drug
Also called ropeginterferon alfa-2b
P1101 (ropeginterferon alfa-2b) will be administered subcutaneously every 2 weeks at the starting dose of 100 μg every two weeks (or 50 μg in patients under another cytoreductive therapy). The dose should be gradually increased by 50 μg every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilization of the hematological parameters is achieved (hematocrit <45%, platelets <400 x 10^9/L and leukocytes <10 x 10^9/L). The maximum recommended single dose is 500 μg injected every two weeks. The dose will be maintained at the highest level which can be tolerated and delivers best possible disease response.
Low-dose aspirinDrug
Also called Low-dose acetylsalicylic acid
Low-dose aspirin (acetylsalicylic acid) (75-150 mg/day) will be given as background therapy during the 12 months of study treatment, unless contraindicated.
PhlebotomyProcedure or surgery
Phlebotomy is performed aiming at a hematocrit < 45%. When the hematocrit value is 45% or higher, phlebotomy is performed. The volume of phlebotomy per procedure should be 200 to 400 mL while monitoring the circulatory dynamics such as blood pressure and pulse. In the elderly and patients with cardiovascular disorders, a small volume (100-200 mL) should be considered to avoid rapid changes in hemodynamics.
| Study group | Role | What they receive |
|---|---|---|
| P1101 | Experimental | Conventional treatment based on phlebotomies, low-dose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of pegylated proline-interferon alpha-2b (P1101, ropeginterferon alfa-2b) once every 2 weeks. Receives: Drug: P1101; Drug: Low-dose aspirin; Procedure: Phlebotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects Who Achieved Durable Phlebotomy-free Complete Hematological Response (CHR) at Month 12
The primary efficacy endpoint was the phlebotomy-free CHR rate at Months 9 and 12.
The phlebotomy-free CHR rate was defined as the proportion of patients who achieved phlebotomy-free CHR at both Months 9 and 12 without phlebotomies during the previous 3 months.
A responder in sense of the primary endpoint was a patient who met all of the following criteria at Months 9 and 12:
Hematocrit <45% phlebotomy-free (absence of phlebotomy during the previous 3 months) Platelet count ≤400 × 10^9/L Leukocyte count ≤10 × 10^9/L
Measured: 12 months
Secondary outcomes (10)
Changes in Hct From Baseline
Hct will be recorded every 3 months.
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Changes in WBC Count From Baseline
WBC count will be recorded every 3 months.
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Changes in Plt Count From Baseline
Plt count will be recorded every 3 months.
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Changes in Spleen Size From Baseline
Spleen size will be recorded every 3 months.
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
Time to Requiring no Phlebotomy
Time to requiring no phlebotomy is recorded.
Measured: Up to 12 months
Time Required to First Response
Time required to first response is defined as time to achieve complete hematological response (CHR) without phlebotomy.
Measured: Up to 12 months
Duration of Response Maintenance
Duration of maintained complete hematologic response (CHR) since first achievement of CHR after administration of the study drug will be calculated.
Measured: Up to 12 months
Proportion of Subjects Without Thrombotic or Hemorrhagic Events
Thrombotic or hemorrhagic events will be recorded any time during the study. The proportion of subjects without thrombotic or hemorrhagic events is defined as the proportion of subjects experienced no thrombotic and hemorrhagic events during the study period (12 months).
Measured: Up to 12 months
Change of JAK2 Mutant Allelic Burden Over Time vs. Baseline
Quantitative JAK2 measurements at screening, Months 3, 6, 9 and 12 (central laboratory) for subjects who signed consent form. Change of JAK2 allelic burden over time will be assessed.
Measured: Baseline, 3 months, 6 months, 9 months and 12 months
PK of P1101
Trough concentration is the measured concentration of a drug at the end of a dosing interval at steady state every 2 weeks.
Additionally, serum concentration is measured at hours 0, 24, 48, 96 and 168 after administration at Week 0 and Week 28.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2019
- Study start20 Dec 2019
- Primary completion8 Mar 2021
- Study completion8 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Polycythemia Vera (PV)Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Conventional treatment based on phlebotomies, low-dose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of P1101 (ropeginterferon alfa-2b) once every 2 weeks
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEssentia Japan K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04182100
- Sponsor's protocol ID
- A19-201
- Status last verified
- Dec 2021
- First submitted
- 15 Nov 2019
- Last updated
- 15 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Qin A, Shimoda K, Suo S, Fu R, Kirito K, Wu D, Liao J, Chen H, Wu L, Su X, Gao Y, Sato T, Li Y, Zhang J, Shen W, Wang W, Zhang L, Jin J, Komatsu N. Population Pharmacokinetics-Pharmacodynamics and Exposure-Response of Ropeginterferon Alfa-2b in Chinese and Japanese Patients With Polycythemia Vera. Pharmacol Res Perspect. 2025 Jun;13(3):e70109. doi: 10.1002/prp2.70109.
PubMed 40313042
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Single Arm Study of Efficacy and Safety of P1101 for Polycythemia Vera (PV) Patients for Whom the Current Standard of Treatment is Difficult to Apply
- ClinicalTrials.gov ID
- NCT04182100
- Acronym / sponsor ID
- A19-201
- Conditions
- Polycythemia Vera (PV)
- Keywords
- Myeloproliferative Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- PharmaEssentia Japan K.K.Industry (pharma, biotech, devices)
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 2 Dec 2019 (actual)
- Results
- Posted 15 Sep 2025
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 Phase 2 single arm study to investigate efficacy and safety of P1101 for adult Japanese patients with PV.
Detailed description
Eligible patients will be treated with P1101, starting at 100 μg (or 50 μg in patients under another cytoreductive therapy). The dose should be gradually increased by 50 μg every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilization of the hematological parameters is achieved (hematocrit <45%, platelets <400 x 10^9/L and leukocytes <10 x 10^9/L). The maximum recommended single dose is 500 μg injected every two weeks.
At week 36 (month 9) and week 52 (month 12), the primary study endpoint, phlebotomy-free CHR, will be analyzed. After completion of the 52-week study duration, provision and administration of P1101, collection of the long-term follow up information (blood parameters, molecular and cytogenetic data, safety parameters and as also the optional bone marrow data) will be continued until the drug becomes commercially available for all study subjects..
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Conventional treatment based on phlebotomies, low-dose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of P1101 (ropeginterferon alfa-2b) once every 2 weeks
| Arm | Type | Receives |
|---|---|---|
| P1101 | Experimental | Drug: P1101, Drug: Low-dose aspirin, Procedure: PhlebotomyConventional treatment based on phlebotomies, low-dose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of pegylated proline-interferon alpha-2b (P1101, ropeginterferon alfa-2b) once every 2 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Male or female patients ≥20 years old
- Patients diagnosed with PV according to the WHO 2008 or WHO 2016 criteria
- PV patients for whom the current standard of treatment is difficult to apply. (Patients with a documented history of refractory to HU are excluded.)
- Total HU treatment duration shorter than 3 years (cumulatively) at screening
- For cytoreduction naïve patients only: PV in need of cytoreductive treatment, defined by fulfilling as one or more of the following criteria at baseline:
Key exclusion criteria (20 listed)
- Patients with symptomatic splenomegaly
- Previous use of IFNα for any indication
- Any contraindications or hypersensitivity to interferon-alfa
- Co-morbidity with severe or serious conditions which may impact patient participation in the study in investigator's opinion
- History of major organ transplantation
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 |
|---|---|---|
| P1101Also: ropeginterferon alfa-2bP1101 (ropeginterferon alfa-2b) will be administered subcutaneously every 2 weeks at the starting dose of 100 μg every two weeks (or 50 μg in patients under another cytoreductive therapy). The dose should be gradually increased by 50 μg every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilization of the hematological parameters is achieved (hematocrit <45%, platelets <400 x 10^9/L and leukocytes <10 x 10^9/L). The maximum recommended single dose is 500 μg injected every two weeks. The dose will be maintained at the highest level which can be tolerated and delivers best possible disease response. | Drug | P1101 |
| Low-dose aspirinAlso: Low-dose acetylsalicylic acidLow-dose aspirin (acetylsalicylic acid) (75-150 mg/day) will be given as background therapy during the 12 months of study treatment, unless contraindicated. | Drug | P1101 |
| PhlebotomyPhlebotomy is performed aiming at a hematocrit < 45%. When the hematocrit value is 45% or higher, phlebotomy is performed. The volume of phlebotomy per procedure should be 200 to 400 mL while monitoring the circulatory dynamics such as blood pressure and pulse. In the elderly and patients with cardiovascular disorders, a small volume (100-200 mL) should be considered to avoid rapid changes in hemodynamics. | Procedure or surgery | P1101 |
Primary outcome
Proportion of Subjects Who Achieved Durable Phlebotomy-free Complete Hematological Response (CHR) at Month 12
Time frame: 12 months
The primary efficacy endpoint was the phlebotomy-free CHR rate at Months 9 and 12. The phlebotomy-free CHR rate was defined as the proportion of patients who achieved phlebotomy-free CHR at both Months 9 and 12 without phlebotomies during the previous 3 months. A responder in sense of the primary endpoint was a patient who met all of the following criteria at Months 9 and 12: Hematocrit <45% phlebotomy-free (absence of phlebotomy during the previous 3 months) Platelet count ≤400 × 10^9/L Leukocyte count ≤10 × 10^9/L
10 secondary outcomes
Changes in Hct From Baseline
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
Changes in WBC Count From Baseline
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
Changes in Plt Count From Baseline
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
Changes in Spleen Size From Baseline
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
Time to Requiring no Phlebotomy
Time frame: Up to 12 months
Time Required to First Response
Time frame: Up to 12 months
Duration of Response Maintenance
Time frame: Up to 12 months
Proportion of Subjects Without Thrombotic or Hemorrhagic Events
Time frame: Up to 12 months
Change of JAK2 Mutant Allelic Burden Over Time vs. Baseline
Time frame: Baseline, 3 months, 6 months, 9 months and 12 months
PK of P1101
Time frame: Up to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40313042Qin A, Shimoda K, Suo S, Fu R, Kirito K, Wu D, Liao J, Chen H, Wu L, Su X, Gao Y, Sato T, Li Y, Zhang J, Shen W, Wang W, Zhang L, Jin J, Komatsu N. Population Pharmacokinetics-Pharmacodynamics and Exposure-Response of Ropeginterferon Alfa-2b in Chinese and Japanese Patients With Polycythemia Vera. Pharmacol Res Perspect. 2025 Jun;13(3):e70109. doi: 10.1002/prp2.70109.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing P1101, Low-dose aspirin and Phlebotomy in people with Polycythemia Vera (PV), run by PharmaEssentia Japan K.K. at 8 sites in Japan.
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 20 inclusion and 20 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: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Japan. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Subjects Who Achieved Durable Phlebotomy-free Complete Hematological Response (CHR) at Month 12 (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04182100, which also lists 1 linked publication.
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 15 Sep 2025.