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Trials
A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

trialsTrialActive

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

A phase 3 trial of Ropeginterferon alfa-2b in myeloproliferative neoplasms, run by PharmaEssentia, active and no longer recruiting.

Overview Connected5

Overview

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV is a phase 3 interventional study registered as NCT05481151 by PharmaEssentia, with 111 participants enrolled, started 2022-10-26 and due to reach its primary completion in 2025-06-30. Interventions recorded: P1101 (Ropeginterferon alfa-2b-njft) and Ropeginterferon alfa-2b-njft (P1101).

Setting

A Phase IIIb, Randomized, Open-Label, Parallel Group, Multicenter Study to Assess Efficacy, Safety, and Tolerability of Two Dosing Regimens of Ropeginterferon Alfa-2b-njft (P1101) in Adult Patients With Polycythemia Vera (PV)

Phase

Phase 3

Sponsor

PharmaEssentia

Registry

Started

2022-10-26

Enrolled

111 enrolled

Connected

Similar pages

Trial
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.
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Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance
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Shares PharmaEssentia, Ropeginterferon alfa-2b, Cytokines & engineered cytokines, Myeloproliferative neoplasms (PV, ET, myelofibrosis).
Treatment
Bomedemstat
Shares Polycythaemia vera (PV), Myeloproliferative neoplasms (PV, ET, myelofibrosis) and the tag pipeline.

cancers

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 strength45/100 · Emerging

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

Phase 3+30
111 enrolled+10
No structured primary endpoint0
Result: active0
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 NCT05481151

Data

JSON ·

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Cancers

Myeloproliferative neoplasms (PV, ET, myelofibrosis)
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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MCP server: npx -y onco-mcp, tools search, get_entity, list_kind, ask, context, compare. This record is get_entity or context with id nct05481151.

WebMCP tools registered on this page: onco_search, onco_get_entity.