Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly

NCT06743035 | Recruiting

• 1 other identifier: IOM-060513
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this non interventional study is to evaluate symptom burden in adult patients with PV without symptomatic splenomegaly during treatment with ropeginterferon alfa-2b in a real-world setting. Further patient-relevant endpoints include effectiveness including complete hematologic response (CHR), event-free survival (EFS), safety and tolerability, treatment reality including dosing details as well as factors affecting treatment decision making.

Conditions

Polycythemia Vera

Keywords

Ropeginterferon alfa-2b; polycythemia vera; symptom burden; myeloproliferative neoplasm

Outcome Measures

Primary Outcomes (1)

• Symptom Burden

  Absolute values of the Myeloproliferative Neoplasm Symptom Assessment Form (MPN-SAF) total symptom score (TSS) at time of study enrollment, during course of study until month 36.

  From Time of enrollment until month 36.

Secondary Outcomes (15)

• Effectiveness: Complete hematologic response (CHR) rate

  From time of treatment start until end of study (max. 54 months after FPI)

• Effectiveness: Event-free survival (EFS)

  From time of treatment start until end of study (max. 54 months after FPI)

• Effectiveness: Proportion of patients with platelet count ≤400 ×109/L

  From time of treatment start until end of study (max. 54 months after FPI)

• Effectiveness: Proportion of patients with WBC count <10 ×109/L

  From time of treatment start until end of study (max. 54 months after FPI)

• Effectiveness: Proportion of patients with HCT value <45%

  From time of treatment start until end of study (max. 54 months after FPI)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients with polycythemia vera (PV) without symptomatic splenomegaly with the decision for treatment with ropeginterferon alfa 2b according to Summary of Product Characteristics (SmPC).

You may qualify if:

• Age ≥18 years
• Confirmed diagnosis of PV without symptomatic splenomegaly
• Indication and decision for treatment with ropeginterferon alfa-2b in accordance with current SmPC
• No prior treatment with ropeginterferon alfa-2b (Patients are allowed to be enrolled up to 6 weeks after their first dose of ropeginterferon alfa-2b but must still be on treatment at the time of enrollment.)
• Dated signature of informed consent form
• Participation in Patient-Reported Outcome (PRO) assessment in German language and completion of questionnaire at time of study enrollment
• Other criteria according to current Summary of Product Characteristics

You may not qualify if:

• Participation in an interventional clinical trial (except follow-up)
• Other contraindications according to current Summary of Product Characteristics

Sponsors & Collaborators

• iOMEDICO AG: lead
• AOP Orphan Pharmaceuticals Germany GmbH: collaborator

Study Sites (1)

Onkologisches Studienzentrum Dr. med. Ingo Zander & Dr. med. Eyck von der Heyde

Hanover, Lower Saxony, 30161, Germany

RECRUITING

MeSH Terms

Conditions

Polycythemia Vera; Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Eyck von der Heyde, Dr.

  Onkologische Schwerpunktpraxis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Laura Serrer

CONTACT

+49 761 15242-0; rope@iomedico.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 19, 2024
• Study Start: December 3, 2024
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2029
• Last Updated: January 9, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)