此為一項第三期雙盲臨床試驗組，旨在測試 Ropeginterferon alfa-2b（P1101）在早期或低至中度風險的原發性骨髓纖維化（PMF）成年患者中的應用。參與者將每兩週接受研究藥物／安慰劑，並每 4 週進行一次評估訪視。研究藥物組與安慰劑組的比例為 2:1。

適應症：Primary Myelofibrosis、Myeloproliferative Neoplasm

收案條件

Male or female patients aged ≥18 years at the time of signing the informed consent form;
Patients with pre-fibrotic/early PMF (Pre-PMF) or overt primary myelofibrosis at low to intermediate-1 risk according to DIPSS plus, diagnosed according to WHO 2016 or 2022 classification;
With good liver function at screening, which is defined as total bilirubin ≤1.5 × upper limit of normal (ULN), international normalized ratio (INR) ≤1.5 × ULN, albumin \>3.5 g/dL, alanine aminotransferase (ALT) ≤2.0 × ULN, and aspartate aminotransferase (AST) ≤2.0 × ULN;
Hgb ≥10.0 g/dL at screening;
Neutrophil count ≥1.0 × 10\^9/L at screening;
Creatinine clearance rate ≥30 mL/min at screening (according to the Cockcroft-Gault formula);
Females of childbearing potential, as well as all women \<2 years after the onset of menopause, must agree to use an acceptable form of birth control until 60 days following the last dose of the study drug, and females must agree to not breastfeed during the study;
Written informed consent obtained from the subject and ability for the subject to comply with the requirements of the study.

Any known contraindications to interferon α or hypersensitivity to interferon α;
Patients with prior interferon therapy having poor tolerability or lack of efficacy to the previous interferon therapy per investigator\'s judgement;
Patients with an ongoing cytoreduction (e.g., HU or IFN-α) at the time of screening if, in the Investigator's opinion, randomizing them into the placebo arm will lead to immediate rebound increase of peripheral blood counts and thus may jeopardize their health status;
With severe or serious diseases that, in the Investigator's opinion, may affect the patient's participation in this study;
History of major organ transplantation;
Pregnant or breastfeeding women;
Patients with any other diseases that will affect the study results or may weaken the compliance to protocol per the Investigator's judgment;
Use any investigational drug \<4 weeks prior to the first dose of study drug, or not recovered from effects of prior administration of any investigational drug.
Eligible for JAK inhibitor therapy at screening.

收案條件維持 ClinicalTrials.gov 原始英文登錄資料，實際收案資格以研究團隊的正式評估與受試者同意書為準。資料來源：ClinicalTrials.gov，每兩週自動更新，最後同步：2026年10月8日。

P1101 用於治療早期 PMF 或低危或中危-1 風險的明顯 PMF 患者