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Clinical Trial Summary

This is a Phase 2 single arm study to investigate efficacy and safety of P1101 for adult Japanese patients with PV.


Clinical Trial Description

Eligible patients will be treated with P1101, starting at 100 μg (or 50 μg in patients under another cytoreductive therapy). The dose should be gradually increased by 50 μg every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilization of the hematological parameters is achieved (hematocrit <45%, platelets <400 x 10^9/L and leukocytes <10 x 10^9/L). The maximum recommended single dose is 500 μg injected every two weeks. At week 36 (month 9) and week 52 (month 12), the primary study endpoint, phlebotomy-free CHR, will be analyzed. After completion of the 52-week study duration, provision and administration of P1101, collection of the long-term follow up information (blood parameters, molecular and cytogenetic data, safety parameters and as also the optional bone marrow data) will be continued until the drug becomes commercially available for all study subjects.. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04182100
Study type Interventional
Source PharmaEssentia Japan K.K.
Contact
Status Completed
Phase Phase 2
Start date December 20, 2019
Completion date March 8, 2021

See also
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Recruiting NCT06002490 - A Study to Evaluate P1101 in Japanese PV Patients Phase 3
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Completed NCT01816256 - Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms N/A
Recruiting NCT04655092 - Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients Phase 3
Completed NCT04243122 - Assessing Feasibility of Thromboprophylaxis With Apixaban in JAK2-positive Myeloproliferative Neoplasm Patients Phase 2
Available NCT04745637 - Managed Access Programs for INC424, Ruxolitinib