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Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Low-Risk Polycythemia Vera

Study Purpose

This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with low-risk PV. Approximately 110 patients with low-risk PV will be enrolled. The whole study period is 108 weeks, including a main treatment phase (56 weeks), an extension treatment phase (48 weeks), and a safety follow-up phase (four weeks).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 59 Years
Gender	All

More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Patients ≥18 and ˂60 years old; 2. PV according WHO 2022 Criteria; 3. Low-risk PV according to the NCCN guideline; 4. Hct value lower than 45%; 5. JAK2 V617F or exon 12 mutation AND a bone marrow biopsy performed with morphology consistent with PV and reticulin fibrosis grade of 0-1; 6. Females of childbearing potential must agree to use an acceptable form of birth control; 7. Written informed consent obtained from the patient or the patient's legal representative.

Exclusion Criteria:

1. Previous well documented cardiovascular PV-related events; 2. Prior use of cytoreductive agents in the past 4 weeks prior to randomization; 3. Any contraindication to pegylated interferon or its excipients; 4. Non-responder or resistance to interferon or any other cytoreductive therapies; 5. Documented autoimmune disease at screening or in the medical history; 6. Prior or current autoimmune thyroid disease; 7. Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening that, in the Investigator's opinion, would jeopardize the safety of the subject or their compliance with the protocol; 8. Infections with systemic manifestations except hepatitis B (HBV) and/or hepatitis C (HCV), at screening; 9. Any investigational drug less than 6 weeks prior to the first dose of study drug; 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; 16. Significant liver or renal disease; 17. History of major organ transplantation; 18. History or presence of clinically significant neurologic diseases; 19. History of malignant disease, including solid tumours and hematological malignancies within the last 3 years.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06290765
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	PharmaEssentia
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Not yet recruiting
Countries
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Polycythemia Vera, Myeloproliferative Neoplasm

Arms & Interventions

Arms

Experimental: Ropeginterferon alfa-2b group

Ropeginterferon alfa-2b subcutaneously (SC) every two weeks (± 3 days), target optimal dose of 500 µg. Phlebotomy should be conducted when Hct ≥ 45%.

Other: Control group

Phlebotomy only and should be conducted when Hct ≥ 45%.

Interventions

Drug: - Ropeginterferon alfa-2b

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.

Procedure: - Phlebotomy

Control group patients will receive phlebotomy only

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Ting-Fang Wang

[email protected]

+886-2-26557688

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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