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

Study Purpose

Objectives: To compare the efficacy and safety in Adult patients (≥18 years) diagnosed as essential thrombocythemia treated with the Pegylated Interferon Alfa-2b vs.#46; Interferon Alfa. Study Design: A prospective, open-label, multicenter, randomized controlled clinical trial.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT05395507
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 2
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Institute of Hematology & Blood Diseases Hospital, China
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Lei Zhang, MD
Principal Investigator Affiliation	Institute of Hematology & Blood Diseases Hospital, China
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	China
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Essential Thrombocytopenia

Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Recombinant Interferon Alpha

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.

Experimental: Pegylated Interferon Alfa-2b

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.

Interventions

Drug: - Recombinant Interferon Alpha

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.

Drug: - Pegylated interferon alfa-2b

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.

Contact a Trial Team

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International Sites

Tianjin, Tianjin, China

Status

Recruiting

Address

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin, 300020

Site Contact

[email protected]

8602223909240

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