An observational study in Polycythemia Vera, sponsored by iOMEDICO AG. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by iOMEDICO AG · Observational
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.
278 studies on the registry are indexed under Polycythemia Vera; 53 are open to participants now.
This study's planned enrollment of 200 is below the median of 240 across 44 observational studies indexed under Polycythemia Vera.
Browse Polycythemia Vera studies →iOMEDICO AG is the lead sponsor of 53 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Time frame: From Time of enrollment until month 36.
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
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
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.
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
Effectiveness: Proportion of patients with platelet count ≤400 ×109/L
Platelet count (descriptive statistics and frequencies ≤400 vs. \> 400 ×109/L)
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
Effectiveness: Proportion of patients with WBC count <10 ×109/L
WBC count (descriptive statistics and frequencies \<10 vs. ≥10 ×109/L)
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
Effectiveness: Proportion of patients with HCT value <45%
HCT value (descriptive statistics and frequencies \<45% vs. ≥45%)
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
Effectiveness: Proportion of patients without phlebotomy during course of study
Proportion of patients without phlebotomy from treatment start until respective time point
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
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
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
Dosing
Dose intensity (average dose in µg/4 weeks) and dose over time per patient and overall
Time frame: From start until end of treatment (max. 54 months after FPI)
Treatment discontinuation
Frequency of treatment discontinuation and reasons thereof
Time frame: From start until end of treatment (max. 54 months after FPI)
(S)ADRs leading to permanent treatment discontinuation
Frequency of patients with (S)ADRs leading to permanent treatment discontinuation
Time frame: From start until end of treatment (max. 54 months after FPI)
Symptom burden
Absolute values of single items regarding symptom burden during course of study until month 36.
Time frame: From time of enrollment until month 36 after treatment start (max. 54 months after FPI)
Treatment reality: previous cytoreductive therapies
Frequency of distinct previous cytoreductive therapies (if applicable)
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
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)
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
Treatment reality: parallel cytoreductive therapies
Frequency of parallel cytoreductive therapies (combinations)
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
Treatment reality: subsequent cytoreductive therapies
Frequency of subsequent cytoreductive therapies (switch to another therapeutic agent)
Time frame: From time of treatment start until end of study (max. 54 months after FPI)
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2024 (actual). Primary completion is estimated for Jul 2029, 55 months after the start.
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