Actively Recruiting
Efficacy and Safety of Peginterferon in ET and PV.
Led by Zhenya Hong · Updated on 2024-12-16
40
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Peginterferon in ET and PV.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet the 2016 WHO diagnostic criteria for Essential Thrombocythemia or Polycythemia Vera
- For Essential Thrombocythemia patients, meet criteria for cytoreductive therapy including age 60 or older regardless of cardiovascular risk or JAK2 mutation, or platelet count over 1500 x 10^9/L, or history of arterial or venous thrombosis
- ECOG performance status score of 2 or less
- Cardiac ejection fraction of 60% or higher
- Voluntarily signed informed consent form
You will not qualify if you...
- Previous treatment with Peginterferon alpha-2b
- Essential Thrombocythemia patients not meeting cytoreductive therapy criteria per 2016 Chinese Expert Consensus
- Allergy to alpha-interferon or any excipients in the product
- History of psychiatric illness or allergy to interferon
- Plasma total bilirubin greater than twice the normal value
- Severe cardiac disease, liver failure, chronic kidney disease, or neurological disorders such as depression or mania
- History of other cancers within the past three years
- Autoimmune chronic hepatitis
- Any condition the investigator considers unsuitable for participation
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Actively Recruiting
Research Team
Z
ZhenYa Hong, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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