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An Observational Study Tracking Changes in JAK2 Gene Mutation After Ropeginterferon Treatment in Patients with Polycythemia Vera

A Prospective, Multicenter, Investigator-Initiated Observational Study of Changes in JAK2 V617F Mutant Allele Burden in Patients with Polycythemia Vera Treated with Ropeginterferon

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0012231
Enrollment
392
Registered
2026-07-06
Start date
2026-10-01
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

None listed

Interventions

None listed

Sponsors

The Catholic University of Korea, Seoul St. Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Adults over 18 years of age 2. Patients diagnosed with polycythemia vera according to the World Health Organization (WHO) criteria 3. Patients who are currently being treated with ropeginterferon after receiving at least one prescription, or who are scheduled to receive Ropeginterferon 4. Patients confirmed to have the JAK2 V617F mutation 5. Patients who have received sufficient explanation about participation in the study and voluntarily signed the Informed Consent Form (ICF)

Exclusion criteria

Exclusion criteria: 1. Patients who, in the investigator’s clinical judgment, are expected to have difficulty with follow-up or with completing study procedures 2. Patients who are deemed unsuitable for study participation due to significant comorbidities or other reasons 3. Patients for whom blood testing or blood sampling is medically contraindicated 4. Patients who discontinued Ropeginterferon more than 6 months prior and have no plan for re-administration 5. Patients with contraindications or hypersensitivity to Ropeginterferon

Design outcomes

Primary

MeasureTime frame
Change in JAK2 V617F allele burden;Achievement of Molecular Response (MR)

Secondary

MeasureTime frame
Event-Free Survival(EFS);Time to MR;Achievement of Complete Hematologic Response (CHR);Time to CHR;Identification of clinical predictors of CHR and MR;Correlation between CHR and MR

Countries

Korea, Republic of

Contacts

Public ContactSung-Eun Lee

The Catholic University of Korea, Seoul St. Mary's Hospital

lee86@catholic.ac.kr+82-2-2258-6058

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Jul 23, 2026