Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Adult Essential Thrombocythemia

• Status: Recruiting
• Trial end date: 2025-06-30
• Target enrollment: 0
• Participant gender: All

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 prospective, open-label, multicenter, randomized controlled clinical trial.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b

Criteria

Inclusion Criteria:

• ≥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 Criteria:

• 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.