Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2026-01-04 @ 12:10 AM
Study NCT ID:
NCT05074550
Status:
UNKNOWN
Last Update Posted:
2023-07-24
First Post:
2021-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Evaluation Study for Patients With Polycythemia Vera
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': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-07-21', 'studyFirstSubmitDate': '2021-09-14', 'studyFirstSubmitQcDate': '2021-10-06', 'lastUpdatePostDateStruct': {'date': '2023-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients Experiencing Treatment-emergent Adverse Events (TEAEs) in the Study', 'timeFrame': '45 weeks'}], 'secondaryOutcomes': [{'measure': 'Evaluation of pharmacokinetics of PPMX-T003 after single dose', 'timeFrame': 'Day1,Day2,Day7', 'description': 'Observed maximum plasma concentration \\[Cmax\\]'}, {'measure': 'Evaluation of pharmacokinetics of PPMX-T003 after single dose', 'timeFrame': 'Day1,Day2,Day7', 'description': 'Terminal elimination rate constant \\[λz\\]'}, {'measure': 'Evaluation of pharmacokinetics of PPMX-T003 after single dose', 'timeFrame': 'Day1,Day2,Day7', 'description': 'Area under the concentration-time curve from pre-dose \\[time 0\\] to the time of the last quantifiable concentration \\[AUC0-t\\]'}, {'measure': 'Evaluation of pharmacokinetics of PPMX-T003 after single dose', 'timeFrame': 'Day1,Day2,Day7', 'description': 'Area under the concentration-time curve from pre-dose \\[time 0\\] extrapolated to infinite time \\[AUC0-inf\\]'}, {'measure': 'Evaluation of pharmacokinetics of PPMX-T003 after single dose', 'timeFrame': 'Day1,Day2,Day7', 'description': 'Apparent terminal half-life \\[t½\\]'}, {'measure': 'Evaluation of pharmacokinetics of PPMX-T003 after single dose', 'timeFrame': 'Day1,Day2,Day7', 'description': 'Apparent systemic clearance \\[CL\\]'}, {'measure': 'Evaluation of pharmacokinetics of PPMX-T003 after single dose', 'timeFrame': 'Day1,Day2,Day7', 'description': 'Volume of distribution \\[Vd\\]'}, {'measure': 'Examining the expression rate of anti-drug antibodies (ADA)', 'timeFrame': 'Day1,Day21,up to 45weeks'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Myeloproliferative neoplasms'], 'conditions': ['Polycythemia Vera']}, 'referencesModule': {'references': [{'pmid': '37552083', 'type': 'DERIVED', 'citation': 'Gorak EJ, Otterstatter M, Al Baghdadi T, Gillis N, Foran JM, Liu JJ, Bejar R, Gore SD, Kroft SH, Harrington A, Saber W, Starczynowski D, Rollison DE, Zhang L, Moscinski L, Wilson S, Thompson J, Borchert C, Sherman S, Hebert D, Walker ME, Padron E, DeZern AE, Sekeres MA. Discordant pathologic diagnoses of myelodysplastic neoplasms and their implications for registries and therapies. Blood Adv. 2023 Oct 24;7(20):6120-6129. doi: 10.1182/bloodadvances.2023010061.'}]}, 'descriptionModule': {'briefSummary': 'This is PhaseI Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of PPMX-T003 in Polycythemia Vera'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of PV according to either the 2008 or 2016 WHO classification criteria\n* PV patients being only treated with phlebotomy and the interval is 4-9 weeks\n\nExclusion Criteria:\n\n* Patients administrated drugs for PV treatment such as hydroxyurea or ruxolitinib (aspirin is excluded)'}, 'identificationModule': {'nctId': 'NCT05074550', 'briefTitle': 'Safety Evaluation Study for Patients With Polycythemia Vera', 'organization': {'class': 'INDUSTRY', 'fullName': 'Perseus Proteomics Inc.'}, 'officialTitle': 'Phase I, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of A Single Intravenous PPMX-T003 in Polycythemia Vera', 'orgStudyIdInfo': {'id': 'PPMX-T003-CT102'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PPMX-T003', 'description': 'This drug should be administered within 48 hours after the phlebotomy. In addition, as a dose escalation design, 4 doses of 0.25 mg/kg, 0.4 mg/kg, 0.64 mg/kg, and 1 mg/kg are administered to the same subject, when the next phlebotomy required during observation period after the 1st administration.', 'interventionNames': ['Drug: PPMX-T003']}], 'interventions': [{'name': 'PPMX-T003', 'type': 'DRUG', 'description': 'As an observation and evaluation method, for each dose, in principle, inpatient observation is performed for 1 week from the day before administration, and then safety and pharmacodynamic tests are evaluated by visiting the hospital every 2 weeks.', 'armGroupLabels': ['PPMX-T003']}]}, 'contactsLocationsModule': {'locations': [{'zip': '573-1191', 'city': 'Hirakata', 'state': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Kansai Medical University Hospital', 'geoPoint': {'lat': 34.81352, 'lon': 135.64914}}, {'zip': '693-8501', 'city': 'Izumo', 'state': 'Shimane', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Shimane University Hospital', 'geoPoint': {'lat': 35.36667, 'lon': 132.76667}}, {'zip': '545-8586', 'city': 'Osaka', 'status': 'RECRUITING', 'country': 'Japan', 'facility': 'Osaka City University Hospital', 'geoPoint': {'lat': 34.69379, 'lon': 135.50107}}], 'centralContacts': [{'name': 'Tadashi Matsuura', 'role': 'CONTACT', 'email': 'tmatsuura@ppmx.com', 'phone': '+81-3-5738-1705'}, {'name': 'Hiroko Akiyoshi', 'role': 'CONTACT', 'email': 'hakiyoshi@ppmx.com', 'phone': '+81-3-5738-1705'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Perseus Proteomics Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}