Ignite Creation Date:
2025-12-24 @ 10:40 PM
Ignite Modification Date:
2025-12-28 @ 6:42 AM
Study NCT ID:
NCT06743035
Status:
RECRUITING
Last Update Posted:
2024-12-24
First Post:
2024-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011087', 'term': 'Polycythemia Vera'}, {'id': 'D009196', 'term': 'Myeloproliferative Disorders'}], 'ancestors': [{'id': 'D019046', 'term': 'Bone Marrow Neoplasms'}, {'id': 'D019337', 'term': 'Hematologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001855', 'term': 'Bone Marrow Diseases'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-19', 'studyFirstSubmitDate': '2024-12-16', 'studyFirstSubmitQcDate': '2024-12-16', 'lastUpdatePostDateStruct': {'date': '2024-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom Burden', 'timeFrame': 'From Time of enrollment until month 36.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Effectiveness: Complete hematologic response (CHR) rate', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': 'CHR rate is defined as the proportion of patients with\n\n* Hematocrit (HCT) \\<45% and\n* Phlebotomy-free (absence of phlebotomy during the previous 3 months) and\n* Platelet count ≤400 x 10\\^9/L and\n* white blood cell count ≤10 x 10\\^9/L'}, {'measure': 'Effectiveness: Event-free survival (EFS)', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': '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.'}, {'measure': 'Effectiveness: Proportion of patients with platelet count ≤400 ×109/L', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': 'Platelet count (descriptive statistics and frequencies ≤400 vs. \\> 400 ×109/L)'}, {'measure': 'Effectiveness: Proportion of patients with WBC count <10 ×109/L', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': 'WBC count (descriptive statistics and frequencies \\<10 vs. ≥10 ×109/L)'}, {'measure': 'Effectiveness: Proportion of patients with HCT value <45%', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': 'HCT value (descriptive statistics and frequencies \\<45% vs. ≥45%)'}, {'measure': 'Effectiveness: Proportion of patients without phlebotomy during course of study', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': 'Proportion of patients without phlebotomy from treatment start until respective time point'}, {'measure': 'Drug safety', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': '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'}, {'measure': 'Dosing', 'timeFrame': 'From start until end of treatment (max. 54 months after FPI)', 'description': 'Dose intensity (average dose in µg/4 weeks) and dose over time per patient and overall'}, {'measure': 'Treatment discontinuation', 'timeFrame': 'From start until end of treatment (max. 54 months after FPI)', 'description': 'Frequency of treatment discontinuation and reasons thereof'}, {'measure': '(S)ADRs leading to permanent treatment discontinuation', 'timeFrame': 'From start until end of treatment (max. 54 months after FPI)', 'description': 'Frequency of patients with (S)ADRs leading to permanent treatment discontinuation'}, {'measure': 'Symptom burden', 'timeFrame': 'From time of enrollment until month 36 after treatment start (max. 54 months after FPI)', 'description': 'Absolute values of single items regarding symptom burden during course of study until month 36.'}, {'measure': 'Treatment reality: previous cytoreductive therapies', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': 'Frequency of distinct previous cytoreductive therapies (if applicable)'}, {'measure': 'Treatment reality: Switch to ropeginterferon alfa-2b', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': 'Reason for switch to ropeginterferon alfa-2b (if applicable) (i.e., frequencies of answers per reasons in the physician´s questionnaire)'}, {'measure': 'Treatment reality: parallel cytoreductive therapies', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': 'Frequency of parallel cytoreductive therapies (combinations)'}, {'measure': 'Treatment reality: subsequent cytoreductive therapies', 'timeFrame': 'From time of treatment start until end of study (max. 54 months after FPI)', 'description': 'Frequency of subsequent cytoreductive therapies (switch to another therapeutic agent)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ropeginterferon alfa-2b', 'polycythemia vera', 'symptom burden', 'myeloproliferative neoplasm'], 'conditions': ['Polycythemia Vera']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Confirmed diagnosis of PV without symptomatic splenomegaly\n* Indication and decision for treatment with ropeginterferon alfa-2b in accordance with current SmPC\n* 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.)\n* Dated signature of informed consent form\n* Participation in Patient-Reported Outcome (PRO) assessment in German language and completion of questionnaire at time of study enrollment\n* Other criteria according to current Summary of Product Characteristics\n\nExclusion Criteria:\n\n* Participation in an interventional clinical trial (except follow-up)\n* Other contraindications according to current Summary of Product Characteristics'}, 'identificationModule': {'nctId': 'NCT06743035', 'acronym': 'ROPE', 'briefTitle': 'Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly', 'organization': {'class': 'INDUSTRY', 'fullName': 'iOMEDICO AG'}, 'officialTitle': 'Ropeginterferon Alfa-2b in Patients With Polycythemia Vera (PV) Without Symptomatic Splenomegaly: A Prospective, Longitudinal, Multicenter, Observational Study in Germany', 'orgStudyIdInfo': {'id': 'IOM-060513'}}, 'contactsLocationsModule': {'locations': [{'zip': '30161', 'city': 'Hanover', 'state': 'Lower Saxony', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Eyck von der Heyde, Dr.', 'role': 'CONTACT', 'email': 'vdheyde@onkologie-am-raschplatz.de', 'phone': '+49511311660'}], 'facility': 'Onkologisches Studienzentrum Dr. med. Ingo Zander & Dr. med. Eyck von der Heyde', 'geoPoint': {'lat': 52.37052, 'lon': 9.73322}}], 'centralContacts': [{'name': 'Laura Serrer', 'role': 'CONTACT', 'email': 'rope@iomedico.com', 'phone': '+49 761 15242-0'}], 'overallOfficials': [{'name': 'Eyck von der Heyde, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Onkologische Schwerpunktpraxis'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'iOMEDICO AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'AOP Orphan Pharmaceuticals Germany GmbH', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}