Actively Recruiting
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)
Led by Zhenya Hong · Updated on 2024-12-16
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Peginterferon alpha-2b in adults with Essential Thrombocythemia (ET) and Polycythemia Vera (PV), two blood disorders characterized by abnormal blood cell production. This single-arm, single-center study aims to enroll 40 participants diagnosed according to specific 2016 WHO criteria. The study focuses on monitoring hematologic remission and other disease-related outcomes over time. Participants will receive a weekly subcutaneous injection of Peginterferon alpha-2b at a dose of 180 mcg. The investigator may adjust the dose based on any adverse events experienced. The study includes follow-up visits to assess the drug's impact on molecular markers, blood cell counts, spleen size, and the occurrence of complications such as thrombosis or progression to other blood diseases. During the study, participants will undergo evaluations at various time points up to 48 weeks, including blood tests to measure remission rates, gene mutation burden, and safety assessments. Researchers will also monitor for bleeding events and disease progression. The total duration of participation and detailed monitoring are designed to understand both the benefits and risks of this treatment in this patient group.
CONDITIONS
Brief 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 (ET) or Polycythemia Vera (PV)
- For ET, must fulfill all four major criteria or first three major plus one secondary criterion
- For PV, must fulfill three major criteria or first two major plus one secondary criterion
- ET patients must meet criteria for cytoreductive therapy, including age 60 or older or specific platelet counts
- ECOG performance status score of 2 or less
- Cardiac ejection fraction (EF) of 60% or higher
- Voluntarily sign the informed consent form
You will not qualify if you...
- Previous treatment with Peginterferon alpha-2b
- ET patients not meeting cytoreductive therapy criteria per 2016 Chinese Expert Consensus
- Allergy to alpha-interferon or any product excipients
- 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, or neurological disorders such as depression or mania
- History of other malignant tumors within the past three years
- Autoimmune chronic hepatitis
- Any condition judged unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 48 weeks
Participants receive Peginterferon α-2b 180 mcg once a week with dose adjustments based on adverse events.
Weekly visits for up to 48 weeks
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
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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