Comparing Pegylated Interferon Alfa-2b and Interferon Alfa for Essential Thrombocythemia

A Prospective, Multicenter, Randomized Controlled Clinical Trial of Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in the Treatment of Adult Essential Thrombocythemia

This study is testing whether Pegylated Interferon Alfa-2b works better and is safer than regular Interferon Alfa for adults with essential thrombocythemia.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 194 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China (other)
• Locations: 1 site (Tianjin, Tianjin)
• Trial ID: NCT05395507 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the efficacy and safety of Pegylated Interferon Alfa-2b versus Interferon Alfa in adult patients diagnosed with essential thrombocythemia. It is a prospective, open-label, multicenter, randomized controlled trial where participants will be randomly assigned to receive either treatment. The initial dosages will be adjusted based on laboratory results and patient tolerance, allowing for flexibility in treatment. The study will monitor the outcomes over a period of 52 weeks.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older diagnosed with essential thrombocythemia who have not used interferon therapy in the past four weeks.

Not a fit: Patients with active thrombosis, severe cardiac or pulmonary dysfunction, or those who have contraindications to interferon will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with essential thrombocythemia.

How similar studies have performed: Other studies have explored interferon therapies for essential thrombocythemia, indicating potential for success, but this specific comparison is novel.

Eligibility 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.

Where this trial is running

Tianjin, Tianjin

• Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin, China (RECRUITING)

Study contacts

• Principal investigator: Lei Zhang, MD — Institute of Hematology & Blood Diseases Hospital, China
• Study coordinator: Lei Zhang, MD

Conditions: Essential Thrombocytopenia, Interferon Alfa, Pegylated Interferon Alfa-2b, Efficacy, Safety