Status:
UNKNOWN
Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Adult Essential Thrombocythemia
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Essential Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Objectives: To compare the efficacy and safety in Adult patients (≥18 years) diagnosed as essential thrombocythemia treated with the Pegylated Interferon Alfa-2b vs. Interferon Alfa. Study Design: A p...
Detailed Description
This is a prospective, open-label, multicenter, randomized controlled clinical trial between Interferon Alfa and Pegylated Interferon Alfa-2b in adult essential thrombocythemia (≥18 years). Patients ...
Eligibility Criteria
Inclusion
- ≥18 years old.
- Male or Female.
- Diagnosis of essential thrombocythemia according to the 2016 World Health Organization criteria.
- Those who have not use interferon within 4 weeks before the first medication.
- Patients with indications for cytoreductive therapy.
- Men and women with reproductive potential, as well as all women with menopause less than 2 years, must agree to use acceptable contraceptive methods until 28 days after the last dose of study drug, and women must agree not to breastfeed during the study period.
- Voluntary written informed consent.
Exclusion
- Resistance, or intolerance, or any contraindications to interferon.
- Patients with active thrombosis or active bleeding.
- Neutrophil count \< 1.0x10\^9/L.
- Hemoglobin \< 11g/dL for male, or \< 10g/dL for female.
- Poor control of thyroid dysfunction.
- Patients with a prior malignancy within the last 3 years.
- Patients with severe cardiac or pulmonary dysfunction.
- Severe renal damage (creatinine clearance \< 30 ml / min).
- Severe liver dysfunction (ALT or AST \> 2.5×ULN).
- Patients with hepatitis B virus, hepatitis C virus replication or HIV infection.
- Patients with a history of drug / alcohol abuse (within 2 years before the study).
- Patients that have participated in other experimental researches within one month before enrollment.
- History of psychiatric disorder.
- Any other circumstances that the investigator considers that the patient is not suitable to participate in the trial.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2025
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT05395507
Start Date
June 1 2022
End Date
June 30 2025
Last Update
July 3 2024
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, China, 300020