此为一项第三期双盲临床试验组，旨在测试 Ropeginterferon alfa-2b（P1101）在早期或低至中度风险的原发性骨髓纤维化（PMF）成年患者中的应用。参与者将每两周接受研究药物／安慰剂，并每 4 周进行一次评估访视。研究药物组与安慰剂组的比例为 2:1。

适应症：Primary Myelofibrosis、Myeloproliferative Neoplasm

入组条件

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.

入组条件维持 ClinicalTrials.gov 原始英文登记资料，实际入组资格以研究团队的正式评估与受试者知情同意书为准。资料来源：ClinicalTrials.gov，每两周自动更新，最后同步：2026年10月8日。

P1101 用于治疗早期 PMF 或低危或中危-1 风险的明显 PMF 患者