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Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients

RECRUITINGPhase 3Sponsored by PharmaEssentia Japan K.K.
Actively Recruiting
PhasePhase 3
SponsorPharmaEssentia Japan K.K.
Started2021-01-19
Est. completion2026-06-30
Eligibility
Age20 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04655092

Summary

This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.

Eligibility

Age: 20 Years+Healthy volunteers accepted
Inclusion Criteria:

* Patients who have completed the 52-week treatment duration in Study A19-201 and are considered by the investigator or sub investigator to be eligible for participation in this study
* Patients who have given written informed consent to participate in this study

Exclusion Criteria:

* Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101

Conditions2

CancerPolycythemia Vera (PV)

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