Safety Evaluation Study for Patients With Polycythemia Vera
NCT ID: NCT05074550
Last Updated: 2023-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
6 participants
INTERVENTIONAL
2022-08-24
2024-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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PPMX-T003
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.
PPMX-T003
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.
Interventions
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PPMX-T003
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.
Eligibility Criteria
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Inclusion Criteria
* PV patients being only treated with phlebotomy and the interval is 4-9 weeks
Exclusion Criteria
20 Years
75 Years
ALL
No
Sponsors
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Perseus Proteomics Inc.
INDUSTRY
Responsible Party
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Locations
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Kansai Medical University Hospital
Hirakata, Osaka, Japan
Shimane University Hospital
Izumo, Shimane, Japan
Osaka City University Hospital
Osaka, , Japan
Countries
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Central Contacts
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References
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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.
Other Identifiers
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PPMX-T003-CT102
Identifier Type: -
Identifier Source: org_study_id
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