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

NCT ID: NCT06743035

Last Updated: 2024-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-03

Study Completion Date

2029-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Polycythemia Vera

Keywords

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Ropeginterferon alfa-2b polycythemia vera symptom burden myeloproliferative neoplasm

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AOP Orphan Pharmaceuticals Germany GmbH

UNKNOWN

Sponsor Role collaborator

iOMEDICO AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eyck von der Heyde, Dr.

Role: PRINCIPAL_INVESTIGATOR

Onkologische Schwerpunktpraxis

Locations

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

Hanover, Lower Saxony, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Laura Serrer

Role: CONTACT

Phone: +49 761 15242-0

Email: [email protected]

Facility Contacts

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Eyck von der Heyde, Dr.

Role: primary

Other Identifiers

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IOM-060513

Identifier Type: -

Identifier Source: org_study_id