Tests peginterferon alpha-2b in adults with essential thrombocythemia or polycythemia vera
Tests a weekly injection of peginterferon in adults with ET or PV.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Peginterferon in ET and PV.
Key facts
- Where
- Wuhan, ChinaSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in China with essential thrombocythemia (ET) or polycythemia vera (PV). Everyone gets a weekly injection of Peginterferon α-2b 180 mcg.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- ET or PV diagnosed by the 2016 WHO criteria. People with ET must also need treatment to lower blood counts: age 60 or older, or a past blood clot, or platelets above 1500 × 10^9/L. ECOG score 2 or lower.
- Earlier treatment
- No earlier treatment with Peginterferon α-2b.
- Biomarker or test result
- JAK2, CALR or MPL mutation for ET. JAK2 V617F or JAK2 exon 12 mutation for PV. Heart ejection fraction of 60% or more.
Main reasons for not taking part
- Allergy to α-interferon or to anything in the product
- History of psychiatric illness
- Severe heart disease, liver insufficiency, chronic kidney disease or nerve disorders such as depression or mania
- Another cancer within the past three years
- Autoimmune chronic hepatitis
Read by machine on 12 November 2026.
Where in China
- Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: ZhenYa HongTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Zhenya Hong
- Trial code
- NCT06734637
- Record updated
- 16 December 2024
- Original description
This is a single-arm, single-center study aims to recruit 40 participants with Essential Thrombocythemia (ET) and Polycythemia Vera (PV). Eligible participants will receive a subcutaneous injection of Peginterferon α-2b 180 mcg once a week and follow-up，and efficacy and safety will be evaluated.Read full original descriptionShow less
A Single-arm, Single-center Study to Explore the Safety and Efficacy of Pegylated Interferon Alpha in Chinese Patients With ET (Essential Thrombocythemia) and PV (Polycythemia Vera).
This is a single-arm, single-center study aims to recruit 40 participants with Essential Thrombocythemia (ET) and Polycythemia Vera (PV). Eligible participants will receive a subcutaneous injection of Peginterferon α-2b 180 mcg once a week and follow-up，and efficacy and safety will be evaluated.
Inclusion: Meet the 2016 WHO diagnostic criteria for ET (Essential Thrombocythemia) and PV (Polycythemia Vera); ET (Essential Thrombocythemia) major criteria:; Platelet count > 450 * 10\^9/L; (2) Bone marrow biopsy shows marked megakaryocytic proliferation with increased mature megakaryocyte volume and increased nuclear lobulation. There is no significant granulocytic proliferation, left shift, or erythroid proliferation, with grade 1 fibrosis observed in a few cases; (3) Does not meet the WHO diagnostic criteria for BCR-ABL1+ CML, PV, PMF, MDS, or other myeloproliferative neoplasms; (4) JAK2, CALR, or MPL mutation positive; Secondary criteria: (1) Presence of a clonal marker or absence of evidence for reactive thrombocytosis; The diagnosis of ET requires the fulfillment of all four main criteria, or the first three main criteria plus one secondary criterion; PV (Polycythemia Vera) main criteria: (1) Hemoglobin > 16.5 g/dL in males, > 16 g/dL in females, or Hematocrit > 49% in males, > 48% in females, or an increase in red cell volume of 25% or more above the normal value; (2) Bone marrow biopsy shows increased cellularity inappropriate for age, with marked erythroid, granulocytic, and megakaryocytic proliferation, and the presence of mature megakaryocytes of varying sizes and morphologies; (3) JAK2 V617F mutation positive or JAK2 exon 12 mutation positive; Secondary criteria: Serum Epo (Erythropoietin) level below the lower limit of the normal range; The diagnosis of PV requires the fulfillment of three major criteria, or the first two main criteria plus one secondary criterion; For ET patients, the criteria for cytoreductive therapy must be met, as follows:; (1) For patients without a history of thrombosis: Age ≥ 60 years, regardless of the presence of cardiovascular risk (CVR) or JAK2V617 mutation; Any age with a platelet count > 1500 × 109/L. (2) For patients with a history of arterial thrombosis: Any age, regardless of the presence of CVR and JAK2V617 mutation; (3) For patients with a history of venous thrombosis: Any age, regardless of the presence of CVR and JAK2V617 mutation; 3.ECOG score ≤ 2. 4.Cardiac ejection fraction (EF) ≥ 60%. 5.The participant voluntarily signs the informed consent form.
Exclusion: Previous treatment with Peginterferon α-2b; ET patients who do not meet the criteria for cytoreductive therapy as per the 2016 Chinese Expert Consensus on Primary Thrombocythemia; Allergy to the active ingredient, α-interferon, or any excipients of this product; History of psychiatric illness, or allergy to interferon; Severe cardiac disease, liver insufficiency, chronic kidney disease, and neurological disorders (such as depression or mania); History of other malignant tumors within the past three years; Autoimmune chronic hepatitis; Any condition deemed unsuitable for inclusion by the investigator; Plasma total bilirubin greater than twice the normal value.