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NCT06002490
A Study to Evaluate P1101 in Japanese PV Patients
Phase 3 trial testing P1101 in Polycythemia Vera (PV) in 21 participants. Completed in 26 July 2024.
26 July 2024
Quick facts
| Lead sponsor | PharmaEssentia Japan K.K. |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 17 October 2023 |
| Primary completion | 26 July 2024 |
| Estimated completion | 26 July 2024 |
| Sites | 6 locations across Japan |
Drugs / interventions tested
- P1101 — full drug profile →
- Low-dose aspirin
- Phlebotomy
Conditions studied
- Polycythemia Vera (PV) — all drugs for Polycythemia Vera (PV) →
Sponsor
PharmaEssentia Japan K.K. — full company profile →
Who can join
18 and older, any sex, with Polycythemia Vera (PV). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a Phase 3 single arm study to investigate efficacy and safety of P1101's rapid titration for adult Japanese patients with PV.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Platelets in cancer and immunotherapy: functional dynamics and therapeutic opportunities.
Cai C, Liu Y, Lu R, Fan X, et al · · 2025 · cited 8× · PMID 40514754 · DOI 10.1186/s40164-025-00676-x -
Efficacy and safety of a three-step dose escalation regimen of ropeginterferon alfa-2b in Japanese patients with polycythemia vera: a phase 3b, single-arm, multicenter study.
Inano T, Sugimoto Y, Ohishi K, Gotoh A, et al · · 2026 · PMID 41801560 · DOI 10.1007/s12185-026-04163-9
Verify or expand the search:
- PubMed search for NCT06002490
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of P1101
Trials testing the same drug.
- NCT04182100 — Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply · Phase 2 · completed
- NCT01933906 — Addition of P1101 to Imatinib Treatment in Patients With Chronic Phase Chronic Myeloid Leukaemia Not Achieving a Complet · Phase 1 · completed
Other recruiting trials for Polycythemia Vera (PV)
Currently open trials in the same condition.
- NCT07362225 — MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myel · recruiting
- NCT07232290 — Phase IIa Study on Flonoltinib Maleate Tablets in the Treatment of Patients With Polycythemia Vera · Phase 2 · recruiting
- NCT04655092 — Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients · Phase 3 · recruiting
Other PharmaEssentia Japan K.K. trials
Trials by the same sponsor.
- NCT04655092 — Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients · Phase 3 · recruiting
- NCT04182100 — Efficacy and Safety of P1101 in Polycythemia Vera Patients for Whom the Standard of Treatment is Difficult to Apply · Phase 2 · completed
- NCT03546465 — Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Cauca · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06002490 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PharmaEssentia Japan K.K.
- Last refreshed: 8 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06002490.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing