NCT05485948

A Phase II Single-Arm Multicenter Study to Access Efficacy and Safety of P1101 in Chinese Polycythemia Vera Patients Who Are Intolerant or Resistance to Hydroxyurea

Active, enrolled Phase 2 Last updated 30 July 2025

What this trial tests

Phase 2 trial testing Ropeginterferon alfa-2b in Polycythemia Vera in 49 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

8 October 2021

Primary endpoint
7 September 2022

1 July 2027

Quick facts

Lead sponsor	PharmaEssentia
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	8 October 2021
Primary completion	7 September 2022
Estimated completion	1 July 2027
Sites	14 locations across China

Drugs / interventions tested

• Ropeginterferon alfa-2b (ROPEGINTERFERON ALFA-2B) — full drug profile →

Conditions studied

• Polycythemia Vera — all drugs for Polycythemia Vera →

Sponsor

PharmaEssentia — full company profile →

Who can join

18 and older, any sex, with Polycythemia Vera. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• The phlebotomy- or erythrocytapheresis-free CHR rate based on the central laboratory test results evaluation
  Time frame: Week 24
  1. Hct \<45% without the use of phlebotomy or erythrocytapheresis (without the use of phlebotomy or erythrocytapheresis within the previous 3 months); 2. PLT count≤400x10\^9/L; 3. WBC count \<10x10\^9/L.

Sponsor's own description

This study is a phase II single-arm study designed to evaluate the efficacy and safety of P1101 in Chinese PV patients who are intolerance or resistance to HU.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. An alternative dosing strategy for ropeginterferon alfa-2b may help improve outcomes in myeloproliferative neoplasms: An overview of previous and ongoing studies with perspectives on the future.
   Qin A, Urbanski RW, Yu L, Ahmed T, et al · · 2023 · cited 26× · PMID 36776307 · DOI 10.3389/fonc.2023.1109866
2. 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.
   Jin J, Zhang L, Qin A, Wu D, et al · · 2023 · cited 20× · PMID 37344895 · DOI 10.1186/s40164-023-00415-0
3. Effective Management of Polycythemia Vera With Ropeginterferon Alfa-2b Treatment.
   Suo SS, Fu RF, Qin A, Shao ZH, et al · · 2024 · cited 17× · PMID 38644985 · DOI 10.14740/jh1245
4. Molecular remission uncoupled with complete haematological response in polycythaemia vera treatment with ropeginterferon alfa-2b.
   Suo S, Fu RF, Qin A, Shao Z, et al · · 2024 · cited 10× · PMID 39462216 · DOI 10.1111/bjh.19846
5. Population Pharmacokinetics-Pharmacodynamics and Exposure-Response of Ropeginterferon Alfa-2b in Chinese and Japanese Patients With Polycythemia Vera.
   Qin A, Shimoda K, Suo S, Fu R, et al · · 2025 · cited 4× · PMID 40313042 · DOI 10.1002/prp2.70109
6. Ropeginterferon alfa-2b shows anti-polycythaemia vera activity without causing clinically significant anaemia.
   Kirito K, Qin A, Suo S, Fu R, et al · · 2024 · cited 4× · PMID 39516248 · DOI 10.1038/s44276-024-00076-4
7. Emerging Significance and Implications of a Durable Complete Molecular Remission in the Treatment of Polycythemia Vera.
   Duan M, Bose P, Hunter AM, Qin A, et al · · 2025 · cited 2× · PMID 41060606 · DOI 10.1007/s11899-025-00758-x
8. Modern and multidisciplinary care in polycythemia vera.
   Palandri F, Sartor C, Pileri A, Addimanda O, et al · · 2026 · PMID 41999414 · DOI 10.1007/s00277-026-06970-w