Evidence map›Paper›PMID 41801560›Full record

Trial reportInternational journal of hematology2026

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.

Tadaaki Inano, Yuka Sugimoto, Kohshi Ohishi, Akihiko Gotoh, Tomoki Ito, Michiko Ichii, Kazuya Shimoda, Sheena Lin, Oleh Zagrijtschuk, Albert Qin and 5 more

Registry-linked trialAbstract readMulticenter StudyClinical Trial, Phase III
PubMed Full text at PMC Publisher
In one paragraph

Trial report in International journal of hematology, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06002490 (A Phase III b, Single-arm, Multicenter, Optimal Dose Finding Study to Assess the Efficacy and Safety of P1101 in Japanese Patients With Polycythemia Vera), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT06002490 phase3completednot on this map

A Phase III b, Single-arm, Multicenter, Optimal Dose Finding Study to Assess the Efficacy and Safety of P1101 in Japanese Patients With Polycythemia Vera (PV).

TypeinterventionalSponsorPharmaEssentia Japan K.K.Ran2023 to 2024Enrolled21ConditionsPolycythemia Vera (PV)ArmsP1101, Low-dose aspirin, Phlebotomy
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Tadaaki InanoDepartment of Hematology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Yuka SugimotoDepartment of Hematology and Oncology, Mie University Graduate School of Medicine, Mie, Japan.
Kohshi OhishiDepartment of Transfusion Medicine and Cell Therapy, Mie University Hospital, Mie, Japan.
Akihiko GotohDepartment of Hematology, Tokyo Medical University, Tokyo, Japan.
Tomoki ItoFirst Department of Internal Medicine, Kansai Medical University, Osaka, Japan.
Michiko IchiiDepartment of Hematology and Oncology, the University of Osaka Graduate School of Medicine, Osaka, Japan.
Kazuya ShimodaDivision of Hematology, Diabetes and Endocrinology, Department of Internal Medicine, Faculty of Medicine, University of Miyazaki, 5200 Kihara, Kiyotake-cho, Miyazaki City, Miyazaki Prefecture, 889‑1692, Japan. kshimoda@med.miyazaki-u.ac.jp.ORCID http://orcid.org/0000-0002-2555-8188
Sheena LinPharmaEssentia Corporation, Taipei, Taiwan.
Oleh ZagrijtschukPharmaEssentia USA Corporation, Burlington, MA, USA.
Albert QinPharmaEssentia Corporation, Taipei, Taiwan.
Mai SatoPharmaEssentia Japan KK, Tokyo, Japan.
Hiroaki KawasePharmaEssentia Japan KK, Tokyo, Japan.
Toshiaki SatoPharmaEssentia Japan KK, Tokyo, Japan.
Norio KomatsuDepartment of Hematology, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Keita KiritoDepartment of Hematology and Oncology, University of Yamanashi, Yamanashi, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Ropeginterferon alfa-2b, a monopegylated interferon α-2b, is a cytoreductive treatment for polycythemia vera (PV). In Japan, the current regimen involves titration in 50-µg increments every 2 weeks until reaching the maximum dose (500 µg), which requires considerable time. This phase 3b, open-label, single-arm, multicenter study (October 2023-July 2024) assessed the efficacy and safety of a three-step dose escalation regimen (day 1: 250 µg, week 2: 350 µg, week 4: 500 µg) of ropeginterferon alfa-2b in Japanese patients with PV (NCT06002490). Twenty-one patients were included (mean age: 57 years); most (95.2%) received ropeginterferon alfa-2b for at least 24 weeks. The complete hematologic response rate (primary endpoint; hematocrit < 45%, no phlebotomy in the previous 12 weeks, platelet count ≤ 400 × 10

Indexed as

Interferon alpha-2Polycythemia VeraPolyethylene GlycolsAdultAgedDose-Response Relationship, DrugDrug Administration ScheduleEast Asian PeopleFemaleHumansInterferon-alphaJapanMaleMiddle AgedRecombinant ProteinsTreatment OutcomeInterferon-alphaInterferon alpha-2peginterferon alfa-2bPolyethylene GlycolsRecombinant ProteinsJapanPolycythemia veraRopeginterferon alfa-2bThree-step dose escalation regimen

Identifiers

PMID41801560
PMCPMC13233951

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.