Can a new drug reduce bloodletting for polycythemia vera?
NCT ID NCT06290765
First seen Jul 31, 2026 · Last updated Jul 31, 2026
Summary
This trial investigates whether ropeginterferon alfa-2b can help people with polycythemia vera, a condition where the body makes too many red blood cells. The study will compare the drug to standard care, which includes phlebotomy (removing blood) and aspirin. About 70 adults with polycythemia vera who need frequent phlebotomies will participate. The goal is to see if the drug can keep blood cell levels under control and reduce the need for phlebotomy.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Ropeginterferon alfa-2b (P1101), given as a subcutaneous injection every two weeks
- What this could lead to
- If successful, this could offer a more effective treatment option for polycythemia vera, helping patients maintain healthy blood cell levels with fewer phlebotomies.
- What could go wrong
- This is a phase 4 trial with a relatively small number of participants (about 70), and results may not apply to all patients. The drug may cause side effects, and its benefit over standard care is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Expected to start
-
Aug 2026
An estimate. Start dates often move.
- Expected to finish
-
Jun 2027
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 59 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥18 years at the time of informed consent (or other age required by local regulations); 2. PV according to the World Health Organization (WHO) 2016 or 2022 Criteria; 3. 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; 4. Have the following hematological values immediately prior to randomization at baseline: 1. Hematocrit \<45%, and 2. WBC ≥4× 109/L, and 3. Platelets ≥100 × 109/L; 5. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. 6. 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; 7. 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; 8. 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; 9. Written informed consent obtained from the patient or the patient's legal representative, and ability for the patient to comply with the study requirements. Exclusion Criteria: 1. Patients requiring phlebotomy at Hct levels ˂45% according to Investigator judgement; 2. Clinically significant thrombosis (e.g., deep vein thrombosis or splenic vein thrombosis) or PV-related bleeding within 2 months prior to randomization; 3. 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); 4. Contraindication to pegylated interferon or its excipients; 5. known resistance or intolerance to interferon based therapies, as judged by Investigator; 6. 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; 7. Pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety or compliance with the protocol; 8. 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; 9. Any investigational drug less than 6 weeks prior to randomization or not recovered from the effects of prior administration of any investigational agent; 10. History or presence of depression requiring treatment with antidepressant; 11. Previous suicide attempts or at any risk of suicide at screening, in the judgement of the Investigator; 12. Any significant morbidity or abnormality which may interfere with the study participation; 13. Pregnant or lactating females; 14. History of alcohol abuse or drug abuse within the last year; 15. Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension); 16. Significant liver (AST or ALT \> 2.5 times ULN) or renal disease (creatinine \> 2 mg/ml); 17. History of major organ transplantation; 18. History or presence of clinically significant neurologic diseases, e.g., uncontrolled severe seizure disorder; 19. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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