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Tests treatment safety and results for Essential Thrombocythemia
Official title Efficacy and Safety of Peginterferon in ET and PV.
ClinicalTrials.gov ID: NCT06734637
What this study is testing
What is Peginterferon α-2b injection?
Peginterferon α-2b injection is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for essential thrombocythemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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...
- For ET patients, the criteria for cytoreductive therapy must be met, as follows: (1) For patients without a history of thrombosis: Age ≥ 60 years...
You likely can't join if
- 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.
- Plasma total bilirubin greater than twice the normal value.
- Severe cardiac disease, liver insufficiency, chronic kidney disease, and neurological disorders (such as depression or mania).
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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.
- Plasma total bilirubin greater than twice the normal value.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.