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Long-term Interferon Therapy for Patients with PV: A Clinical Study on the Efficacy and Safety (IIT Study)

Long-term Interferon Therapy for Patients with PV: A Clinical Study on the Efficacy and Safety (IIT Study)

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600120230
Enrollment
Unknown
Registered
2026-03-11
Start date
2026-03-16
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Polycythemia Vera (PV)??

Interventions

Peginterferon alfa-2b Injection Treatment Group:None
Hydroxyurea Treatment Group:None

Sponsors

Shengjing Hospital of China Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with PV; 2. Age 18–65 years (inclusive); 3. Treatment-naïve patients, or those previously treated with HU or short-acting interferon with a washout period of more than 3 months; 4. ECOG score <= 2; 5. Serum creatinine <1.5 × ULN, serum bilirubin <=2.0 × ULN; 6. Subjects voluntarily provided signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Previous treatment with long-acting interferon; 2. Allergy to the active ingredient, alpha-interferon, or any excipient of the investigational product; 3. Autoimmune chronic hepatitis, immune-mediated rheumatological disease, etc.; 4. Severe liver dysfunction or decompensated cirrhosis; 5. History of severe cardiac disease, including unstable or uncontrolled cardiac conditions within the past 6 months; 6. History of severe psychiatric disorders, particularly depression; 7. Pregnant or breastfeeding women, women planning pregnancy, or men with reproductive plans; 8. Severe renal disease (undergoing hemodialysis) or epilepsy (requiring anticonvulsant therapy); 9. History of other malignancies; 10. Previous history of organ transplantation; 11. Individuals deemed ineligible for the trial by the investigator.

Design outcomes

Primary

MeasureTime frame
6-month complete hematological response (CHR) rate;12-month complete hematological response (CHR) rate;24-month complete hematological response (CHR) rate;—

Secondary

MeasureTime frame
24-month molecular response rate.;12-month molecular response rate.;Change from baseline in the MPN-10 Total Symptom Score (TSS) assessing symptom burden at 12 and 24 months of treatment.;—

Countries

China

Contacts

Public ContactLiao Aijun

Shengjing Hospital of China Medical University

liaoaijun@sina.com+86 189 4025 9833

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026