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

trialsTrialRecruiting

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

A phase 3 trial of Ropeginterferon alfa-2b in myeloproliferative neoplasms, run by PharmaEssentia Japan K.K., now recruiting.

Overview Connected6

Overview

Extension Study of P1101 After Completion of Phase 2 Study in PV Patients or Phase 3 Study in ET Patients is a phase 3 interventional study registered as NCT04655092 by PharmaEssentia Japan K.K., with 67 participants planned, started 2021-01-19 and due to reach its primary completion in 2026-06-30. Interventions recorded: P1101 (Ropeginterferon alfa-2b).

Setting

Extension Study of P1101 in Japanese Patients Who Have Completed Phase 2 Single Arm Study in Polycythemia Vera (PV) Patients (Study A19-201) or Phase 3 Study in Essential Thrombocythemia (ET) Patients (Study P1101 ET)

Phase

Phase 3

Sponsor

PharmaEssentia Japan K.K.

Registry

Started

2021-01-19

Enrolled

67 enrolled

Connected

Similar pages

Trial
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET
Shares PharmaEssentia, Ropeginterferon alfa-2b, Essential thrombocythaemia (ET), Cytokines & engineered cytokines and the tag pipeline.
Trial
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV
Shares PharmaEssentia, Ropeginterferon alfa-2b, Polycythaemia vera (PV), Cytokines & engineered cytokines and the tag pipeline.
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A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU
Shares PharmaEssentia, Ropeginterferon alfa-2b, Polycythaemia vera (PV), Cytokines & engineered cytokines and the tag pipeline.
Trial
Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance
Shares PharmaEssentia, Ropeginterferon alfa-2b, Essential thrombocythaemia (ET), Cytokines & engineered cytokines and the tag pipeline.
Treatment
Bomedemstat
Shares Essential thrombocythaemia (ET), Polycythaemia vera (PV), Myeloproliferative neoplasms (PV, ET, myelofibrosis) and the tag pipeline.
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INTREPID: A Study of Sapablursen Evaluating the Safety and Efficacy in Participants With Polycythemia Vera (PV)
Shares Polycythaemia vera (PV), Myeloproliferative neoplasms (PV, ET, myelofibrosis) and the tag pipeline.
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A Study of Low Dose Interferon Alpha Versus Hydroxyurea in Treatment of Chronic Myeloid Neoplasms
Shares Essential thrombocythaemia (ET), Polycythaemia vera (PV) and the tag pipeline.
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A Phase 2, Open-Label Study of DISC-3405 in Participants With Polycythemia Vera (PV)
Shares Polycythaemia vera (PV), Myeloproliferative neoplasms (PV, ET, myelofibrosis) and the tag pipeline.

cancers

Essential thrombocythaemia (ET)Myeloproliferative neoplasms (PV, ET, myelofibrosis)Polycythaemia vera (PV)

technologies

Cytokines & engineered cytokines

drugs

ApprovedLong-acting mono-pegylated interferon alfa

Ropeginterferon alfa-2b · Besremi

companies

Evidence strength44/100 · Emerging

How much and what kind of evidence, not how big the benefit. Click for the breakdown.

Phase 3+30
67 enrolled+9
No structured primary endpoint0
Result: recruiting0
No independent replication recorded0
A linked product is approved+5

Formula disclosed on the evidence page.

ProvenanceLast edited 2026-09-22 · Jude Gomila · Wave 2 corpus-only joins applied · diff · file

Sources & links

ClinicalTrials.gov NCT04655092

Data

JSON ·

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Cancers

Myeloproliferative neoplasms (PV, ET, myelofibrosis)
Essential thrombocythaemia (ET)
Polycythaemia vera (PV)

Technologies

Cytokines & engineered cytokines

Products

Ropeginterferon alfa-2b

Companies

PharmaEssentia

Not yet reviewedNeeds expert (clinical) review. Review this page or see the review queue and roster.

Model panel commentary is coming to this page: machine commentary, not clinical review.

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