Last reviewed · How we verify
NCT05482971
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET
Phase 2 trial testing Ropeginterferon alfa-2b-njft (P1101) in Essential Thrombocythemia in 91 participants. Participants enrolled and being followed up; not accepting new ones.
9 May 2025
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 | 91 |
| Start date | 29 September 2022 |
| Primary completion | 9 May 2025 |
| Estimated completion | 31 March 2027 |
| Sites | 34 locations across Canada, United States |
Drugs / interventions tested
- Ropeginterferon alfa-2b-njft (P1101) — full drug profile →
Conditions studied
- Essential Thrombocythemia — all drugs for Essential Thrombocythemia →
Sponsor
PharmaEssentia — full company profile →
Who can join
18 and older, any sex, with Essential Thrombocythemia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia
Publications & conference data
7 peer-reviewed publications reference this trial (live from Europe PMC):
-
PEGylated therapeutics in the clinic.
Gao Y, Joshi M, Zhao Z, Mitragotri S. · · 2024 · cited 133× · PMID 38193121 · DOI 10.1002/btm2.10600 -
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 -
Interferons in the treatment of myeloproliferative neoplasms.
Vachhani P, Mascarenhas J, Bose P, Hobbs G, et al · · 2024 · cited 14× · PMID 38380373 · DOI 10.1177/20406207241229588 -
ROP-ET: a prospective phase III trial investigating the efficacy and safety of ropeginterferon alfa-2b in essential thrombocythemia patients with limited treatment options.
Kiladjian JJ, Marin FF, Al-Ali HK, Alvarez-Larrán A, et al · · 2024 · cited 12× · PMID 38438627 · DOI 10.1007/s00277-024-05665-4 -
SOHO State of the Art Update and Next Questions: Novel Therapies for Polycythemia Vera.
Masarova L, Chifotides HT. · · 2024 · cited 5× · PMID 38135633 · DOI 10.1016/j.clml.2023.11.004 -
A multicenter study to assess efficacy, safety, and tolerability of ropeginterferon alfa-2b-njft in patients with essential thrombocythemia in the US and Canada: EXCEED-ET trial.
Masarova L, Reeves BN, El Chaer F, Foltz L, et al · · 2025 · cited 1× · PMID 40330782 · DOI 10.3389/fmed.2025.1548590 -
The Dual Role of Interferon Signaling in Myeloproliferative Neoplasms: Pathogenesis and Targeted Therapeutics.
Bonuomo V, Dogliotti I, Masucci S, Grano S, et al · · 2025 · PMID 41228273 · DOI 10.3390/cancers17213480
Verify or expand the search:
- PubMed search for NCT05482971
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Ropeginterferon alfa-2b-njft (P1101)
Trials testing the same drug.
- NCT05481151 — A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV · Phase 3 · active not recruiting
Other recruiting trials for Essential Thrombocythemia
Currently open trials in the same condition.
- NCT06661915 — A Randomized Study of ASTX727 With or Without Iadademstat in Advanced Myeloproliferative Neoplasms (MPNs) · Phase 2 · recruiting
- NCT06734637 — Efficacy and Safety of Peginterferon in ET and PV. · NA · recruiting
- NCT06456346 — Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007) · Phase 3 · recruiting
- NCT06361641 — Functional and Phenotypic Characterization of Monocytes in Myeloproliferative Syndromes · NA · recruiting
- NCT06378437 — A Study of GLB-001 in Patients With Myeloid Malignancies · Phase 1 · recruiting
Other PharmaEssentia trials
Trials by the same sponsor.
- NCT06290765 — Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera · Phase 4 · not yet recruiting
- NCT06468033 — P1101 in Treating Patients With Early PMF or Overt PMF at Low or Intermediate-1 Risk · Phase 3 · recruiting
- NCT07053904 — Phase I Open-Label Study of P1101 Followed by P1801 in Advanced Solid Tumors · Phase 1 · enrolling by invitation
- NCT06698861 — A Phase I PK/PD Study of PEG-MetHuG-CSF (P2203) in Healthy Volunteers · Phase 1 · completed
- NCT06665776 — HLA-A*02:01 Allele Frequency and the NY-ESO-1 Expression Status in Cancer Patients in Taiwan · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05482971 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by PharmaEssentia
- Last refreshed: 13 August 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05482971.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing