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NCT Number: NCT06743035

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

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.

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Key information

Conditions

Polycythemia Vera Bone Marrow Diseases Bone Marrow Neoplasms Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Myeloproliferative Disorders Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Hanover, Lower Saxony, 30161, Germany

Location status: Recruiting

Location contact

Eyck von der Heyde, Dr.

CONTACT

[email protected]

+49511311660

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Symptom Burden

    Time frame: From Time of enrollment until month 36.

    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.

Secondary outcomes

  1. Effectiveness: Complete hematologic response (CHR) rate

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

    CHR rate is defined as the proportion of patients with

    • Hematocrit (HCT) <45% and
    • Phlebotomy-free (absence of phlebotomy during the previous 3 months) and
    • Platelet count ≤400 x 10^9/L and
    • white blood cell count ≤10 x 10^9/L

  2. Effectiveness: Event-free survival (EFS)

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

    EFS is defined as the time from the first administration of ropeginterferon alfa-2b until the first occurrence of a thromboembolic event, disease progression to post-PV myelofibrosis, acute myeloid leukemia (AML) transformation, or death, whichever comes first. Patients without any event at the time point of analysis will be censored with their respective date of last contact.

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

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

    Platelet count (descriptive statistics and frequencies ≤400 vs. > 400 ×109/L)

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

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

    WBC count (descriptive statistics and frequencies <10 vs. ≥10 ×109/L)

  5. Effectiveness: Proportion of patients with HCT value <45%

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

    HCT value (descriptive statistics and frequencies <45% vs. ≥45%)

  6. Effectiveness: Proportion of patients without phlebotomy during course of study

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

    Proportion of patients without phlebotomy from treatment start until respective time point

  7. Drug safety

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

    Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs) and serious adverse drug reactions (SADRs) related to ropeginterferon alfa-2b as characterized by severity, and seriousness

  8. Dosing

    Time frame: From start until end of treatment (max. 54 months after FPI)

    Dose intensity (average dose in µg/4 weeks) and dose over time per patient and overall

  9. Treatment discontinuation

    Time frame: From start until end of treatment (max. 54 months after FPI)

    Frequency of treatment discontinuation and reasons thereof

  10. (S)ADRs leading to permanent treatment discontinuation

    Time frame: From start until end of treatment (max. 54 months after FPI)

    Frequency of patients with (S)ADRs leading to permanent treatment discontinuation

  11. Symptom burden

    Time frame: From time of enrollment until month 36 after treatment start (max. 54 months after FPI)

    Absolute values of single items regarding symptom burden during course of study until month 36.

  12. Treatment reality: previous cytoreductive therapies

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

    Frequency of distinct previous cytoreductive therapies (if applicable)

  13. Treatment reality: Switch to ropeginterferon alfa-2b

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

    Reason for switch to ropeginterferon alfa-2b (if applicable) (i.e., frequencies of answers per reasons in the physician´s questionnaire)

  14. Treatment reality: parallel cytoreductive therapies

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

    Frequency of parallel cytoreductive therapies (combinations)

  15. Treatment reality: subsequent cytoreductive therapies

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

    Frequency of subsequent cytoreductive therapies (switch to another therapeutic agent)

Study contacts

Contact information is provided by the study sponsor or research team.

Laura Serrer

CONTACT

[email protected]

+49 761 15242-0

Sponsors and collaborators

Lead sponsor

iOMEDICO AG

Industry

Collaborators

  • AOP Orphan Pharmaceuticals Germany GmbH

Registry information

Official study title

Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly: A Prospective, Longitudinal, Multicenter, Observational Study in Germany

Acronym: ROPE

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Dec 19, 2024
Registry last updated
Jan 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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