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Polycythemia VeraROPENCT06743035

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

An observational study of Polycythemia Vera, run by iOMEDICO AG at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Polycythemia Vera
How many people
200 participants
Where
1 siteGermany
Study dates
3 Dec 2024to Jul 2029
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Laura Serrer contact

+49 761 15242-0

rope@iomedico.com

Germany1 site, 1 recruiting

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

    Hanover, Lower Saxony, 30161

    Eyck von der Heyde, Dr., +49511311660, vdheyde@onkologie-am-raschplatz.de

    Recruiting

Other trials in Germany

About this study

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

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.

Keywords
Ropeginterferon alfa-2b, polycythemia vera, symptom burden, myeloproliferative neoplasm
Medical subject headings
Polycythemia Vera, Myeloproliferative Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From Time of enrollment until month 36.

Secondary outcomes (15)

  1. Effectiveness: Complete hematologic response (CHR) rate

    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

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

  2. Effectiveness: Event-free survival (EFS)

    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.

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

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

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

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

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

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

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

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

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

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

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

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

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

  7. Drug safety

    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

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

  8. Dosing

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

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

  9. Treatment discontinuation

    Frequency of treatment discontinuation and reasons thereof

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

  10. (S)ADRs leading to permanent treatment discontinuation

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

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

  11. Symptom burden

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

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

  12. Treatment reality: previous cytoreductive therapies

    Frequency of distinct previous cytoreductive therapies (if applicable)

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

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

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

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

  14. Treatment reality: parallel cytoreductive therapies

    Frequency of parallel cytoreductive therapies (combinations)

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

  15. Treatment reality: subsequent cytoreductive therapies

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2024
  2. Study start3 Dec 2024
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06743035
Sponsor's protocol ID
IOM-060513
Acronym
ROPE
Status last verified
Jan 2026
First submitted
16 Dec 2024
Last updated
9 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Polycythemia Vera, run by iOMEDICO AG at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Laura Serrer (+49 761 15242-0, rope@iomedico.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Symptom Burden (time frame: From Time of enrollment until month 36.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06743035.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.

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