Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Adult Essential Thrombocythemia (NCT05395507) | Clinical Trial Compass
UnknownPhase 2
Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Adult Essential Thrombocythemia
China194 participantsStarted 2022-06-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Complete hematological remission (CHR) rates
Timeframe: From the start of study treatment (Week 0) up to the end of Week 52
Trial details
NCT IDNCT05395507
SponsorInstitute of Hematology & Blood Diseases Hospital, China