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

Last updated: July 1, 2024
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Overall Status: Active - Recruiting

Phase

2

Condition

Dysfunctional Uterine Bleeding

Thrombosis

Idiopathic Thrombocytopenic Purpura (Itp)

Treatment

Pegylated interferon alfa-2b

Recombinant Interferon Alpha

Clinical Study ID

NCT05395507
IIT2022004
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • ≥18 years old.

  • Male or Female.

  • Diagnosis of essential thrombocythemia according to the 2016 World HealthOrganization 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 lessthan 2 years, must agree to use acceptable contraceptive methods until 28 days afterthe last dose of study drug, and women must agree not to breastfeed during the studyperiod.

  • Voluntary written informed consent.

Exclusion

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 monthbefore enrollment.

  • History of psychiatric disorder.

  • Any other circumstances that the investigator considers that the patient is notsuitable to participate in the trial.

Study Design

Total Participants: 194
Treatment Group(s): 2
Primary Treatment: Pegylated interferon alfa-2b
Phase: 2
Study Start date:
June 01, 2022
Estimated Completion Date:
June 30, 2025

Study 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 will be randomly divided into the following two treatment groups: 1. Recombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available. 2. Pegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52.

The dosage will be adjusted according to the results of laboratory examinations and patient tolerance. The patient will be transferred to the other group if intolerance or resistance occurs.

Connect with a study center

  • Institute of Hematology & Blood Diseases Hospital

    Tianjin, Tianjin 300020
    China

    Active - Recruiting

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