drugset / Trial / NCT05482971
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of P1101 in Adults With ET
NaSingle-groupOpen-labelTreatment
Summary
A Single-arm, Multicenter Study to Assess the Efficacy, Safety, and Tolerability of Ropeginterferon alfa-2b-njft (P1101) in Adult Patients with Essential Thrombocythemia
Timeline
- Start
- 2022-09-29
- Primary completion
- 2025-05-09
- Completion
- 2027-03-31
Publications
- Reeves BN, El Chaer F, Foltz L, Tashi T, Abu-Zeinah G, Qin A, Lucas J, Halpern AB, Maze D, Safah H, O'Connell CL, Goel S, Rein L, Fang B, How J, Babu S, Li Z, Cerquozzi S, Oh ST, Hunter AM, Podoltsev N, Vachhani P, Cunningham JM, Hillis C, Bose P, Yacoub A, Mascarenhas J, Zagrijtschuk O, Castro H, Mesa RA, Masarova L. Ropeginterferon alfa-2b-njft treatment in essential thrombocythemia across different driver mutations: results from a North American, single-arm, multicentre study (EXCEED-ET). Lancet Reg Health Am. 2026 Jun 10;61:101529. doi: 10.1016/j.lana.2026.101529. eCollection 2026 Sep.
- Masarova L, Reeves BN, El Chaer F, Foltz L, Tashi T, Abu-Zeinah G, Lucas J, Halpern AB, Maze D, Qin A, Safah H, Lan F, O'Connell CL, Goel S, Rein L, Fang B, How J, Babu S, Li Z, Cerquozzi S, Oh ST, Hunter AM, Podoltsev N, Vachhani P, Yacoub A, Cunningham JM, Hillis C, Otoukesh S, Zagrijtschuk O, Castro H, Bose P. 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. Front Med (Lausanne). 2025 Apr 17;12:1548590. doi: 10.3389/fmed.2025.1548590. eCollection 2025.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ropeginterferon alfa-2b | Protein / enzyme biologic | 500 ug | Subcutaneous |