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Study for the effect of pegylated interferon alpha-2b on the short-term effect and long-term disease progression in MPN patients

Study for the effect of pegylated interferon alpha-2b on the short-term effect and long-term disease progression in MPN patients

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900025081
Enrollment
Unknown
Registered
2019-08-10
Start date
2019-08-15
Completion date
Unknown
Last updated
2019-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myeloproliterative neoplasms

Interventions

one:pegylated interferon a-2b, 90-360ug/ week
two:interferon a-2b, 9-42 million IU/ week

Sponsors

The Second Hospital of Tianjin Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. For patients diagnosed with MPN and without any previous treatment, the diagnostic criteria are: Chinese expert consensus on diagnosis and treatment of primary myelofibrosis (2015 edition), Chinese expert consensus on diagnosis and treatment of polycythemia vera (2016), and Chinese expert consensus on diagnosis and treatment of primary thrombocytosis (2016 edition). 2. Aged 18 years or older. 3. MPN patients with initial treatment/patients with 2-week washout period after treatment. 4. The ECOG score is 0-2. 5. PLT> 90*10^9/L,neutrophil>1.5*10^9/L,HB>100g/L. 6. TSH is at normal levels. 7. ALT and AST40 mL/min. 9. Any fertile male or female patient must agree to use an effective contraceptive method throughout the study and at least 6 weeks after the last study treatment. According to the researchers, a patient's fertility means that he or she is biologically capable of having children and having a normal sex life. Female patients without fertility (i.e., meeting at least one of the following criteria) : 1) hysterectomy or bilateral oophorectomy has been performed, or 2) ovarian failure is medically confirmed as postmenopausal (menopause for at least 12 consecutive months in the absence of pathological or physiological reasons). 10. Patients signed written informed consent to participate in this study.

Exclusion criteria

Exclusion criteria: 1. Patients with acute thyroiditis; 2. Psychological diseases such as depression; 3. Autoimmune hepatitis or a history of autoimmune diseases; 4. A history of serious heart disease, including unstable or uncontrolled heart disease within 6 months; 5. Previous history of organ transplantation; 6. Pregnancy and lactation; 7. Any other circumstances that the investigator does not consider appropriate for the patient to participate in this study.

Design outcomes

Primary

MeasureTime frame
hematologic response;Molecular response;

Countries

China

Contacts

Public ContactBai Jie

The Second Hospital of Tianjin Medical University

janebai86@126.com+86 13820525296

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026