Ropeginterferon alfa-2b

DRUG14 trials

Sponsors

Mayo Clinic, PharmaEssentia Japan K.K., PharmaEssentia, The University of Hong Kong, National Taiwan University Hospital

Conditions

Atypical Chronic Myeloid LeukemiaCOVID-19Chronic Hepatitis B Virus InfectionChronic Myelomonocytic LeukemiaCutaneous T Cell LymphomaEssential ThrombocythemiaHealthy VolunteersHepatitis D

Phase 1

Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects

CompletedNCT03546465

PharmaEssentia Japan K.K.Healthy Volunteers

Start: 2018-05-07End: 2019-07-15Updated: 2019-11-26

Ropeginterferon in Patients w/Cutaneous T-Cell Lymphoma (CTCL)

RecruitingNCT07047885

H. Lee Moffitt Cancer Center and Research InstituteCutaneous T Cell Lymphoma

Start: 2025-08-27End: 2028-06-01Target: 38Updated: 2026-04-01

Phase 2

P1101 in Treating Patients With Myelofibrosis

TerminatedNCT02370329

Mayo ClinicPrimary Myelofibrosis, Secondary Myelofibrosis

Start: 2015-08-12End: 2023-11-30Updated: 2025-10-27

Ropeginterferon Alfa 2b for Early Myelofibrosis

The University of Hong KongMyelofibrosis, Primary Myelofibrosis, Prefibrotic Stage

Start: 2021-09-01End: 2025-12-31Target: 50Updated: 2022-10-06

A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection

National Taiwan University HospitalHepatitis D

Start: 2023-02-24End: 2025-08-31Target: 30Updated: 2022-12-29

A Study to Access Efficacy and Safety of P1101 in Chinese PV Patients Who Are Intolerant or Resistance to HU

Active, not recruitingNCT05485948

PharmaEssentiaPolycythemia Vera

Start: 2021-10-08End: 2027-07-31Updated: 2025-08-03

Clinical Study for the Efficacy and Safety of Ropeginterferon Alfa-2b in Adult COVID-19 Patients With Comorbidities

National Taiwan University HospitalCOVID-19

Start: 2023-05-15End: 2024-12-31Target: 60Updated: 2023-04-11

Ropeginterferon Alfa-2b for the Treatment of Myelodysplastic Syndrome/Myeloproliferative Neoplasm Overlap Syndromes and Chronic Myelomonocytic Leukemia

Not yet recruitingNCT07468916

Jonsson Comprehensive Cancer CenterAtypical Chronic Myeloid Leukemia, Chronic Myelomonocytic Leukemia, Myelodysplastic/Myeloproliferative Neoplasm +2

Start: 2026-09-29End: 2032-09-30Target: 35Updated: 2026-05-06

A Clinical Trial of Bomedemstat in Participants With Polycythemia Vera (MK-3543-025)

Not yet recruitingNCT07722611

Merck Sharp & Dohme LLCPolycythemia Vera

Start: 2026-09-21End: 2032-11-30Target: 380Updated: 2026-07-23

Phase 3

Ropeginterferon Alfa-2b (P1101) vs. Anagrelide in Essential Thrombocythemia Patients With Hydroxyurea Resistance or Intolerance

Active, not recruitingNCT04285086

PharmaEssentiaEssential Thrombocythemia

Start: 2020-08-25End: 2029-08-31Updated: 2026-07-22

P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk

Active, not recruitingNCT06468033

PharmaEssentiaMyeloproliferative Neoplasm, Primary Myelofibrosis

Start: 2025-07-18End: 2029-01-11Updated: 2026-08-13

Phase 4

Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera

WithdrawnNCT06290765

PharmaEssentiaMyeloproliferative Neoplasm, Polycythemia Vera

Start: 2026-08-01End: 2027-06-30Updated: 2026-07-31

Unknown Phase

Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

National Taiwan University HospitalChronic Hepatitis B Virus Infection

Start: 2021-05-04End: 2024-12-30Target: 90Updated: 2022-12-27

Observational Study on the Use of Ropeginterferon Alfa-2b in Polycythemia Vera (ROPEG-PV)

RecruitingNCT06506084

FROM- Fondazione per la Ricerca Ospedale di Bergamo- ETSPolycythemia Vera

Start: 2022-09-08End: 2029-12-31Target: 429Updated: 2026-07-09

Related Papers

Integrated analysis of the ropeginterferon alfa-2b clinical program in essential thrombocythemia to demonstrate molecular and hematologic responses with safety profile information across treatment lines, ethnicities, and driver mutation types.

Journal of Clinical Oncology2026-05-27

Ropeginterferon alfa-2b for pre-fibrotic myelofibrosis and lower-risk myelofibrosis requiring cytoreduction.

2026-03-24

Trial in progress: A phase I/ib dose-finding study of ropeginterferon alfa-2b (P1101) in patients with cutaneous T-cell lymphoma (CTCL)

Blood2025-11-03

Ropeginterferon alfa-2b in 248 patients with polycythemia vera: Results from the italian cohort of a prospective, non-interventional, post-authorization study (ROPEG-PV)

Blood2025-11-03

Ropeginterferon alfa-2b in hydroxyurea-intolerant or hydroxyurea-refractory essential thrombocythaemia (SURPASS ET): a multicentre, open-label, randomised, active-controlled, phase 3 study.

2025-11-01

Ropeginterferon alfa-2b versus anagrelide for the treatment of essential thrombocythemia: Topline results of the phase 3 SURPASS-ET trial.

Journal of Clinical Oncology2025-05-283 citations

Ropeginterferon alfa-2b for pre-fibrotic primary myelofibrosis and DIPSS low/intermediate-risk myelofibrosis.

Journal of Clinical Oncology2025-05-281 citations

Population Pharmacokinetics‐Pharmacodynamics and Exposure‐Response of Ropeginterferon Alfa‐2b in Chinese and Japanese Patients With Polycythemia Vera

Pharmacology Research & Perspectives2025-05-015 citations

Paradigm-PV: A Global, Randomized, Multicenter, Two-Arm Phase IV Study to Assess the Efficacy and Safety of Ropeginterferon Alfa-2b in Low- and High-Risk Patients with Polycythemia Vera

Blood2024-11-05

HOPE-PMF: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b in Patients with Early/Lower-Risk Primary Myelofibrosis

Blood2024-11-05

ROP-ET: a prospective phase III trial investigating the efficacy and safety of ropeginterferon alfa-2b in essential thrombocythemia patients with limited treatment options.

2024-03-0411 citations

Study Protocol of a Randomized Controlled Clinical Trial to Evaluate the Efficacy and Safety of Ropeginterferon Alfa-2b in COVID-19 Patients with Comorbidities.

2023-11-27

A new dosing regimen of ropeginterferon alfa-2b is highly effective and tolerable: findings from a phase 2 study in Chinese patients with polycythemia vera.

2023-06-2119 citations

Efficacy and Safety of Ropeginterferon Alfa-2b for Pre-Fibrotic Primary Myelofibrosis and DIPSS Low/Intermediate-1 Risk Myelofibrosis

Blood2022-11-153 citations

SURPASS-ET: phase III Study of Ropeginterferon Alfa-2b versus Anagrelide as Second-Line Therapy in Essential Thrombocythemia

Future Oncology2022-08-0438 citations

Surpass-ET Trial: A Phase 3, Open-Label, Multicenter, Randomized, Active-Controlled Study to Assess Pharmacokinetics and Compare the Efficacy, Safety, and Tolerability of P1101 Vs Anagrelide As Second Line Therapy for Essential Thrombocythemia

Blood2021-11-051 citations

Pharmacokinetics and Pharmacodynamics of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects After Single Subcutaneous Administration.

2021-03-1623 citations