Efficacy and Safety of Ropeginterferon Alfa 2b (P1101) for Patients With Polycythemia Vera - A Randomized Open Label Global Multicenter Study (PARADIGM-PV)

This is a randomized, open-label, multicenter, two-arm study to assess the efficacy and safety of ropeginterferon alfa-2b for patients with PV. The entire study period is 60 weeks, including a main treatment phase (32 weeks), an extension treatment phase (24 weeks), and a safety follow-up phase (four weeks). However, the study may be extended for additional period of treatment after Week 60 pending the primary endpoint analysis at Week 32. Approximately 70 patients with PV will be enrolled.

开始日期2025-01-01

申办/合作机构

药华医药股份有限公司

NCT06770842

/ Not yet recruiting临床2期

Safety and Efficacy of Ropeginterferon Alfa-2b in Combination With Ruxolitinib in Patients With Myelofibrosis Demonstrating Suboptimal Response to Ruxolitinib Monotherapy

In this open-label single arm phase 2 study, approximately 20 patients with MF demonstrating suboptimal response to ruxolitinib monotherapy will be enrolled. Patients will continue to receive ruxolitinib at a stable dose and ropeginterferon alfa 2b will be added to the regimen.

开始日期2025-01-01

申办/合作机构

香港大学

NCT06468033

/ Not yet recruiting临床3期

A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Study to Assess Efficacy and Safety of Ropeginterferon Alfa-2b (P1101) in Adult Patients With Pre-fibrotic/Early Primary Myelofibrosis (PMF) or Overt PMF at Low or Intermediate-1 Risk According to DIPSS Plus

This is a phase 3 double-blind clinical trial arm to test Ropeginterferon alfa-2b (P1101) in adult patients with Primary Myelofibrosis (PMF) at early stage or low to medium risk.
Participants will receive the study drug/placebo bi-weekly and have an assessment visit every 4 weeks. The ratio of study drug to placebo group is 2:1.

开始日期2024-12-01

申办/合作机构

药华医药股份有限公司

100 项与罗培干扰素α-2b 相关的临床结果

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100 项与罗培干扰素α-2b 相关的转化医学

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100 项与罗培干扰素α-2b 相关的专利（医药）

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333

项与罗培干扰素α-2b 相关的文献（医药）

2024-12-01·Blood Research

Treatment with ropeginterferon alfa-2b in patients with hydroxyurea resistant or intolerant polycythemia vera in South Korea: one-year results from a phase 2 study

Letter

作者: Yoon, Seug Yun ; Lee, Sung-Eun

2024-12-01·BRITISH JOURNAL OF HAEMATOLOGY

Molecular remission uncoupled with complete haematological response in polycythaemia vera treatment with ropeginterferon alfa‐2b

Letter

作者: Zhang, Sujiang ; Xiao, Zhijian ; Suo, Shanshan ; Zhang, Lei ; Zuo, Xuelan ; Bai, Jie ; Fu, Rong Feng ; Chen, Suning ; Zhang, Xuhan ; Xu, Na ; Li, Pei ; Qin, Albert ; Wang, Li ; Shao, Zonghong ; Zhang, Jingjing ; Du, Xin ; Duan, Minghui ; Wu, Daoxiang ; Zhou, Hu ; Jin, Jie

2024-12-01·INTERNATIONAL JOURNAL OF HEMATOLOGY

Long-term safety and efficacy of ropeginterferon alfa-2b in Japanese patients with polycythemia vera

Article

作者: Takenaka, Katsuto ; Ichii, Michiko ; Sato, Toshiaki ; Inano, Tadaaki ; Zagrijtschuk, Oleh ; Komatsu, Norio ; Kawase, Hiroaki ; Qin, Albert ; Shirane, Shuichi ; Kirito, Keita ; Gotoh, Akihiko ; Sugimoto, Yuka ; Shimoda, Kazuya ; Ito, Masafumi

Abstract:

Ropeginterferon alfa-2b (ropegIFN), a new-generation interferon-based agent, has been approved in Japan for patients with polycythemia vera (PV) who are ineligible for or respond inadequately to conventional treatment. However, long-term outcomes with ropegIFN in Japanese patients have not been reported. This extension of a phase 2 study of ropegIFN in Japanese patients with PV aimed to determine its long-term safety/efficacy, and changes over time in JAK2 V617F allele burden. Here, we report data from the phase 2 study and subsequent extension over a period of 36 months. The primary endpoint was the complete hematologic response (CHR) maintenance rate without phlebotomy (hematocrit value < 45% without phlebotomy during the previous 12 weeks, platelet count ≤ 400 × 109/L, and white blood cell count ≤ 10 × 109/L). The CHR maintenance rates were 8/27 (29.6%), 18/27 (66.7%), and 22/27 (81.5%) at 12, 24, and 36 months, respectively. No thrombotic or hemorrhagic events occurred. The median allele burden change from baseline was − 74.8% at 36 months. All patients experienced adverse events; 25/27 (92.6%) experienced adverse drug reactions (ADRs), but no serious ADRs or deaths occurred. This interim analysis demonstrated the safety and efficacy of ropegIFN over 36 months in Japanese patients with PV.

项与罗培干扰素α-2b 相关的新闻（医药）

2025-01-06

·Business Wire

PharmaEssentia Announces Positive Topline Phase 3 Data from SURPASS-ET Study Evaluating Ropeginterferon Alfa-2b-njft (P1101) for Essential Thrombocythemia

BURLINGTON, Mass.--( BUSINESS WIRE )-- PharmaEssentia Corporation (TWSE: 6446), a global biopharmaceutical innovator based in Taiwan leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, today announced positive topline results from its SURPASS-ET clinical trial of ropeginterferon alfa-2b-njft (P1101) in patients with essential thrombocythemia (ET). The trial achieved its primary endpoint, showing durable hematologic responses in patients treated with P1101 with a manageable safety profile and no treatment-related serious adverse events. Ropeginterferon alfa-2b-njft is currently FDA approved and marketed as BESREMi® and indicated for polycythemia vera (PV). The Company plans to seek a label expansion to include ET. SURPASS-ET Clinical Results Clinical Trial Overview SURPASS-ET ( NCT04285086 ) is a global Phase 3, randomized, open-label, active-controlled clinical trial evaluating the efficacy, safety and tolerability of P1101 versus Anagrelide as a second-line therapy for ET for 12 months. A total of 174 patients were enrolled, with 91 randomly assigned to the P1101 treatment group and 83 to the Anagrelide group. Primary Endpoint The trial successfully met its primary endpoint, demonstrating durable clinical response as measured using modified European Leukemia Net (ELN) criteria. Among the intent-to-treat (ITT) population, 42.9% (39/91) of participants in the P1101 group achieved durable responses at months 9 and 12, compared to 6.0% (5/83) in the comparator arm (administered Anagrelide) (p=0.0001). P1101 exhibited a manageable safety profile with no treatment-related serious adverse events. Secondary Endpoint: The JAK2 V617F allelic burden was assessed at baseline and 12 months, showing a decrease from 33.7% to 25.3% (-8.4% change) in the P1101 group, compared to a reduction from 39.7% to 37.3% (-2.4% change) in the Anagrelide group. These results suggest that P1101 may have a greater impact on addressing the underlying disease pathology compared to Anagrelide. “We are extremely proud of the SURPASS-ET Phase 3 study outcome, which shows the potential of P1101 as an important new treatment option for patients with ET, a rare blood cancer that drastically increases the risk of heart attack or stroke,” said Ko-Chung Lin, Ph.D., Founder and CEO of PharmaEssentia. “The data highlight the broad potential to apply our innovative monopegylated, long-acting interferon technology as a significant step forward for treating ET, and potentially other myeloproliferative neoplasms, with non-chemotherapy treatments. We plan to leverage these data to expand the existing P1101 product label and further expand the reach of P1101 to address this growing global unmet medical need.” PharmaEssentia plans to present detailed clinical trial results, including additional pharmacokinetics and biomarker data, at a later date. The Company also intends to pursue regulatory discussions with the FDA to expand the existing label for P1101 to include a new potential indication of ET and anticipates regulatory submission by the end of 2025. “The results of the SURPASS-ET trial are significant,” said Albert Qin, M.D., Ph.D., Chief Medical Officer. “ET is a challenging condition associated with symptoms and risks of thrombosis and disease progression. These encouraging results highlight the potential of P1101 to provide an effective and tolerable new treatment option that we believe could provide a substantial clinical benefit for patients with ET. We plan to submit these results to the FDA and other regulatory agencies as soon as possible in hopes of providing this potential new treatment option to patients with ET.” The Company is also evaluating P1101 in ET patients in its EXCEED-ET ( NCT05482971 ) clinical trial in North America. This Phase 2b clinical trial is a single-arm, multicenter trial designed to assess the efficacy, safety, and tolerability of P1101 in adult patients with ET. The company expects to present data from this clinical trial in the second half of 2025. About Essential Thrombocythemia Essential thrombocythemia is a chronic, rare blood disorder that is the most common type of myeloproliferative neoplasm. Essential thrombocythemia is most often caused by genetic mutations that cause the bone marrow to produce too many platelets, which can obstruct blood flow and cause a stroke, heart attack or pulmonary embolism. It is estimated that approximately 148,000 people in the U.S. have ET, which can significantly impact quality of life due to burdensome symptoms. Patients diagnosed with ET face limited treatment options to manage their condition, particularly in reducing the risk of thrombosis and slowing disease progression. About BESREMi® (ropeginterferon alfa-2b-njft) in polycythemia vera (PV) BESREMi is an innovative monopegylated, long-acting interferon with marketing authorization in PV. With its unique pegylation technology, BESREMi has a long duration of activity in the body and is aimed to be administered once every two weeks (or every four weeks with hematological stability for at least one year), allowing flexible dosing that helps meet the individual needs of patients. BESREMi has been approved in more than 40 countries, with approval from the European Medicines Agency (EMA) in 2019, by the US Food and Drug Administration (FDA) in 2021, and by the Pharmaceuticals and Medical Devices Agency (PMDA) in Japan in 2023. It was invented by PharmaEssentia and is manufactured in the company’s Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018. PharmaEssentia retains full global intellectual property rights for the product in all indications. BESREMi was approved with a boxed warning for risk of serious disorders including aggravation of neuropsychiatric, autoimmune, ischemic and infectious disorders. Please see full Prescribing Information , including Boxed Warning. About PharmaEssentia PharmaEssentia (TWSE: 6446), headquartered in Taipei, Taiwan, is a global and rapidly growing biopharmaceutical innovator. Leveraging deep expertise and proven scientific principles, PharmaEssentia aims to deliver effective new biologics for challenging diseases in the areas of hematology, oncology, and immunology with one approved product and a diversifying pipeline. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today PharmaEssentia is expanding its global presence with operations in the U.S., Japan, China, and Korea, along with a world-class biologics production facility in Taichung, Taiwan. For more information about PharmaEssentia USA, visit the website , LinkedIn or X (formerly Twitter).

临床2期临床结果临床3期上市批准免疫疗法

2024-12-10

·PRNewswire

Genetic Profile Linked with High-Altitude Andean Population Correlates with Better Response to Treatment for Myeloproliferative Neoplasms

Variants could serve as biomarker to inform prognosis or guide treatment decisions LBA-4: Andean Enriched NFKB1 Haplotype Reduces Inflammation and Improves Response to Ropeginterferon Alfa-2b in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) SAN DIEGO, Dec. 10, 2024 /PRNewswire/ -- A study presented during the 66th American Society of Hematology (ASH) Annual Meeting and Exposition reveals genetic factors that can affect the molecular pathways involved in inflammation, hypoxia sensing, blood clots, and the response to treatment among people with polycythemia vera (PV) and essential thrombocythemia (ET), part of a group of blood cancers known as myeloproliferative neoplasms. Researchers reported that patients with a genetic profile common among the Aymara Indigenous community in the Andean mountains – namely the NFKB1 gene variant that encodes several different mRNA transcripts – correlated with a lower expression of genes involved in inflammation and a better response to Ropeginterferon-α, the primary drug used to treat PV and ET. The findings could help doctors tailor treatments based on a person's inherited genes, which interact with acquired genetic mutations that cause PV and ET. This may eventually lead to opportunities to develop new therapies for PV and ET, according to researchers. "We identified some genetic variants which are evolutionarily selected to be beneficial to the Aymara high-altitude population in the Andean mountains, and we have now shown, for the first time, that these variants are also present in other populations and correlate with some differences in disease phenotype," said the study's senior author, Josef T. Prchal, MD, a physician and professor of hematology and genetics at the Huntsman Cancer Institute at the University of Utah, Salt Lake City. "Our study suggests that with genotyping, the NFKB1 variant can be used as a biomarker for determining which patients may be more or less responsive to Ropeginterferon-α treatment." In PV, the bone marrow produces too many red blood cells, and in ET, the bone marrow overproduces platelets. Both PV and ET lead to chronic inflammation, raise the risk of dangerous blood clots, and can lead to leukemia. They can also boost hypoxia-inducible factors (HIFs), which can modify how certain genes help cancer cells survive in low-oxygen environments, making the cancer harder to eradicate. For the study, the researchers analyzed genetic profiles, gene expression, and clinical outcomes among 30 people with PV and 15 people with ET. They assessed patients' expression of genes involved in inflammation, HIF targets, and thrombosis (the formation of blood clots). The researchers also analyzed the linkages between a person's NFKB1 genotype and their likelihood of achieving a complete hematologic response (a return to normal blood counts) after Ropeginterferon-α treatment. The genetic markers used in the study reflect three genotypes of the NFKB1 variant (rs230511), delineated as C/C, C/T, and T/T. In previous studies, the research team estimated that the T variant (either C/T or T/T) is present in about 90% of people in the Aymara community and in about 30% of people of European, Asian, and Hispanic ancestry. In the Aymara population, the T variant was also correlated with increased inflammation in immune quiescence, or baseline immune, status, while under inflammatory stress, T variants exhibited a protective role by preventing excessive inflammatory gene expression. In this study, the researchers found that the T variant was associated with decreased inflammatory, prothrombotic, and HIF activity, and a better response to Ropeginterferon-α in PV and ET, which are characterized by chronic inflammation. "Most high-altitude adaptation studies correlate genes with phenotypes such as high hemoglobin or low oxygen saturation, but the important finding that our study adds is that there is also an association with modulation of inflammation, which can affect outcomes for diseases like PV and ET," said Dr. Prchal. "The people with a better response to Ropeginterferon-α showed more C/T genotype which was correlated with less inflammatory gene expression, so we suspect that people with this genotype will also tolerate the treatment better and have fewer side effects." The formation of dangerous blood clots is the major cause of illness and death related to PV and ET, and this risk is known to increase with age. According to the researchers, the new study findings suggest that genetic factors could also play a role in thrombotic risk, potentially in addition to other factors such as diet or environment. While the study points to molecular markers associated with inflammation and thrombosis, the researchers noted that further studies are required to determine whether these markers also correlate with clinical outcomes such as the development of blood clots or leukemia, or whether a person's genetic profile may affect their overall risk of developing myeloproliferative neoplasms. They added that it could also be helpful to study any differences in the C/T versus T/T genotype to further inform treatment decisions. The study was funded by the National Institutes of Health's National Heart, Lung, and Blood Institute and Dorothy Brown Innovation in Science. Jihyun Song, PhD, of Huntsman Cancer Institute at the University of Utah, will discuss this study in the Late-Breaking Abstracts session on Tuesday, December 10, 2024, at 7:30 a.m. Pacific time in Hall B (San Diego Convention Center). About the American Society of Hematology The American Society of Hematology (ASH) (hematology.org) is the world's largest professional society of hematologists dedicated to furthering the understanding, diagnosis, treatment, and prevention of disorders affecting the blood. Since 1958, the Society has led the development of hematology as a discipline by promoting research, patient care, education, training, and advocacy in hematology. The Blood journals () are the premier source for basic, translational, and clinical hematological research. The Blood journals publish more peer-reviewed hematology research than any other academic journals worldwide. SOURCE American Society of Hematology WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ASH会议临床结果

2024-11-26

·ioncology

2024 ASH重磅丨六项LBA摘要公布，一文了解血液学最前沿

编者按第66届美国血液学会（ASH）年会将于2024年12月7～10日在美国圣迭戈（San Diego）盛大召开。作为全球血液学领域规模最大、涵盖最全面的国际学术盛会之一，每年吸引着成千上万名来自世界各地的专家学者，分享最前沿的血液学进展和突破性临床数据。当地时间11月25日，大会官网公布了本次入选的最新重磅摘要（Late-Breaking Abstracts，LBA）共6项，将由研究者于当地时间2024年12月10日上午7:30至9:00，在会议现场Hall B (San Diego Convention Center)进行报告。本刊第一时间整理这6项LBA的核心要点，供大家提前阅览。 01 LBA-1 标题：Tafasitamab Plus Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma: Results from a Phase 3 Study (inMIND) 中文标题：坦昔妥单抗联合来那度胺和利妥昔单抗治疗复发或难治性滤泡性淋巴瘤：III期研究（inMIND）结果汇报人：Laurie H. Sehn（BC癌症中心淋巴瘤中心，加拿大）研究结论在来那度胺和利妥昔单抗的基础上加用坦昔妥单抗，显著且有临床意义地改善了无进展生存期（PFS），使复发/难治性滤泡性淋巴瘤（R/R FL）患者的疾病进展、复发或死亡风险降低了57%。尽管总生存期（OS）数据尚不成熟，但观察到了一种有利于塔坦昔妥单抗的趋势。其安全性特征可控，且与预期毒性一致。本研究首次验证了将两种单克隆抗体（抗CD19与抗CD20）联合用于淋巴瘤治疗的有效性。坦昔妥单抗+来那度胺+利妥昔单抗既可在社区环境中使用，也可在学术环境中使用，是R/R FL患者潜在的新标准治疗选择。 02 LBA-2 标题：Identification of Hepatic-like Erythropoietin with Enhanced Activity As a New Cause of Hereditary and Acquired Erythrocytosis 中文标题：识别具有增强活性的肝样促红细胞生成素作为遗传性和获得性红细胞增多症的新原因汇报人：Betty Gardie[巴黎高等研究实践学院（EPHE），法国] 研究结论本研究报告了一种名为肝样促红细胞生成素增多症（HEP）的新型继发性红细胞增多症，其特征是产生具有非典型糖基化模式和活性增强的肝样促红细胞生成素（EPO）。这种新型EPO在所有遗传性EPO突变型红细胞增多症患者、与肝病相关的红细胞增多症病例以及新生儿中均有观察到。有趣的是，新生儿体内从更活跃的肝型EPO向肾型EPO的转变，可能解释了生命最初几周内血红蛋白水平显著下降的典型现象。因此，在进行特发性和遗传性红细胞增多症的诊断时，将定量和定性EPO筛查作为生物学检查的一部分是至关重要的。 03 LBA-3 标题：Extended Treatment of Venous Thromboembolism with Reduced- Vs Full-Dose Direct Oral Anticoagulants in Patients at High Risk of Recurrence 中文标题：比较减剂量与全剂量直接口服抗凝药延长治疗高风险复发静脉血栓栓塞症 Francis Couturaud（布雷斯特大学、FCRIN INNOVTE网络，法国）研究结论在需要延长抗凝治疗的静脉血栓栓塞症患者中，尚无法证明使用减剂量与全剂量直接抗凝药物在预防静脉血栓栓塞症复发方面的非劣效性。在减剂量组，临床相关出血以及静脉血栓栓塞症复发或临床相关出血的复合终点发生率均低于全剂量组，且这一优势并未因死亡或动脉血栓栓塞事件风险增加而抵消。 04 LBA-4 标题：Andean Enriched NFKB1 Haplotype Reduces Inflammation and Improves Response to Ropeginterferon Alfa-2b in Polycythemia Vera (PV) and Essential Thrombocythemia (ET) 中文标题：富含安第斯特征的NFKB1单倍型可降低真性红细胞增多症（PV）和原发性血小板增多症（ET）患者的炎症水平，并提高对罗培干扰素α-2b的应答率汇报人：Jihyun Song（亨斯迈癌症研究所，美国）研究结论本研究显示，与NFKB1野生型等位基因相比，富含艾马拉族特征的NFKB1 rs230511单倍型可降低真性红细胞增多症（PV）和原发性血小板增多症（ET）患者的炎症、促血栓形成及缺氧诱导因子（HIF）活性。此外，NFKB1 rs230511单倍型还能调节PV和ET患者对罗培干扰素的应答。携带NFKB1 rs230511 T等位基因的患者，其炎症和HIF靶向基因的表达降低，这可能潜在地减少PV和ET患者的炎症和血栓形成风险。携带C/T基因型的患者更有可能实现完全血液学缓解（CHR），这表明这种NFKB1单倍型可能影响罗培干扰素的治疗效果，并可作为评估PV和ET患者治疗应答的潜在生物标志物。这些新的见解对我们理解炎症和促血栓形成过程具有重要意义，并可能为PV和ET的新型疗法提供线索。 05 LBA-5 标题：Outcome of Cerebral Vasculopathy and Cognitive Performances 10 Years Post-Enrollment in the Drepagreffe Trial Comparing Allogeneic Stem Cell Transplantation to Standard-Care in Children with Sickle Cell Anemia and History of Abnormal Cerebral Velocities 中文标题：Drepagreffe试验中接受异体干细胞移植与标准治疗的镰状细胞贫血症伴异常脑血流速度病史患儿的10年脑血管病变情况及认知功能结局比较汇报人：Françoise Bernaudin（巴黎东部大学，法国）研究结论这项首个前瞻性比较试验表明，异体干细胞移植（alloSCT）与标准治疗（SoC）之间的差异在10年后发生了显著变化，其中异体干细胞移植在无症状性脑梗死（SCI)方面提供了更好的一级预防效果，同时改善了患者的社会生活质量、工作记忆和处理速度。 06 LBA-6 标题：Lack of Benefit of Autologous Hematopoietic Cell Transplantation (auto-HCT) in Mantle Cell Lymphoma (MCL) Patients (pts) in First Complete Remission (CR) with Undetectable Minimal Residual Disease (uMRD): Initial Report from the ECOG-ACRIN EA4151 Phase 3 Randomized Trial 中文标题：自体造血干细胞移植（auto-HCT）对首次完全缓解（CR）且无法检测到微小残留病（uMRD）的套细胞淋巴瘤（MCL）患者（pts）无益处：ECOG-ACRIN EA4151 III期随机试验的初步报告汇报人：Timothy S. Fenske（威斯康星医学院，美国）研究结论本次中期分析显示，在高效诱导和维持治疗方案时代，首次完全缓解（CR）且无法检测到微小残留病（uMRD）的套细胞淋巴瘤（MCL）患者并未从巩固性自体造血干细胞移植（auto-HCT）中获益。而诱导治疗后MRD仍为阳性的患者可能从auto-HCT中获益。更长时间的随访对于证实这些发现至关重要。（来源：《肿瘤瞭望–血液时讯》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

临床3期临床结果

100 项与罗培干扰素α-2b 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11027	罗培干扰素α-2b	L03AB15	DB15119

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
真性红细胞增多症	欧盟	Aop Orphan Pharmaceuticals GmbH	2019-02-15
真性红细胞增多症	冰岛	Aop Orphan Pharmaceuticals GmbH	2019-02-15
真性红细胞增多症	列支敦士登	Aop Orphan Pharmaceuticals GmbH	2019-02-15
真性红细胞增多症	挪威	Aop Orphan Pharmaceuticals GmbH	2019-02-15

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适应症	最高研发状态	国家/地区	公司	日期
原发性骨髓纤维化	临床3期	-	药华医药股份有限公司	2024-12-01
原发性血小板增多症	临床3期	美国	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	中国	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	日本	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	加拿大	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	中国香港	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	新加坡	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	韩国	药华医药股份有限公司	2020-08-25
原发性血小板增多症	临床3期	中国台湾	药华医药股份有限公司	2020-08-25
慢性丙型肝炎	临床3期	中国	诺思格（北京）医药科技股份有限公司	2019-05-22

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04285086 (EXCEED-ET, Biospace) 人工标引	临床3期	原发性血小板增多症二线	174	P1101 (Ropeginterferon alfa-2b-njft)	夢膚淵齋構艱襯壓鹽衊(觸簾蓋淵壓窪範窪餘衊) = 膚餘獵齋觸壓膚廠餘鏇醖廠蓋齋淵鹹鹽築獵窪 (醖衊夢糧醖獵範艱糧醖 ) 达到更多	积极	2025-01-06
NCT04285086 (EXCEED-ET, Biospace) 人工标引	临床3期	原发性血小板增多症二线	174	Anagrelide	夢膚淵齋構艱襯壓鹽衊(觸簾蓋淵壓窪範窪餘衊) = 願壓壓醖鏇艱築遞簾壓醖廠蓋齋淵鹹鹽築獵窪 (醖衊夢糧醖獵範艱糧醖 ) 达到更多	积极	2025-01-06
EHA2024 人工标引	临床2期	真性红细胞增多症 JAK2V617F VAF \| IFNL4	114	Ropeginterferon alfa-2b (Ropeg)	醖齋糧鬱襯膚衊遞糧壓(艱憲選鑰壓積製簾鏇鬱) = 積鑰淵餘選鏇醖鏇鏇簾夢窪顧積齋獵願齋廠齋 (繭顧鬱廠憲積餘簾醖範 )	积极	2024-05-14
EHA2024 人工标引	临床2期	真性红细胞增多症 JAK2V617F VAF \| IFNL4	114	Ropeginterferon alfa-2b (Ropeg)py, STD)	醖齋糧鬱襯膚衊遞糧壓(艱憲選鑰壓積製簾鏇鬱) = 艱艱網夢鏇廠蓋蓋膚襯夢窪顧積齋獵願齋廠齋 (繭顧鬱廠憲積餘簾醖範 )	积极	2024-05-14
EUCTR2012-005259-18-CZ \| EUCTR2014-001357-17-PL (PROUD-PV, EHA2024) 人工标引	临床3期	真性红细胞增多症 JAK2V617F allele burden	169	ropeginterferon alfa-2b	鏇鏇鬱觸蓋蓋顧繭觸鬱(構膚壓觸築糧顧網觸醖) = 網鹽遞鹹獵繭壓憲鹽醖遞廠鏇夢廠範顧膚廠鬱 (鏇艱膚艱鑰鏇觸淵獵築 ) 更多	积极	2024-05-14
	临床3期	真性红细胞增多症 JAK2V617F allele burden	169	HU/BAT	鏇鏇鬱觸蓋蓋顧繭觸鬱(構膚壓觸築糧顧網觸醖) = 願糧淵鹽簾齋艱鏇獵膚遞廠鏇夢廠範顧膚廠鬱 (鏇艱膚艱鑰鏇觸淵獵築 ) 更多	积极	2024-05-14
EHA2024	临床3期	真性红细胞增多症	34	Ropeginterferon alfa-2b	壓淵構選淵夢築觸製鬱(積鏇繭壓鬱淵襯構淵窪) = One patient developed autoimmune thyroiditis without the need to suspend treatment 窪觸繭顧鏇獵鏇艱窪襯 (壓憲夢築顧鏇膚壓廠淵 ) 更多	积极	2024-05-14
PROUD-PV/CONTINUATION (EHA2024)	临床3期	二线 JAK2 mutated	12	Ropeginterferon alfa-2b	網鹹鹹艱網醖範壓積繭(壓鹽簾鬱憲鬱選鏇構壓) = One withdrew therapy due to intolerance (flushing and eczema, grade 1) after 9 months of treatment 鹹餘願餘觸選觸襯蓋觸 (醖願齋齋糧淵網構製遞 )	积极	2024-05-14
EHA2024	临床2期	真性红细胞增多症 JAK2 V617F allele burden	27	Ropeginterferon alfa-2b	鹹糧鹽廠壓艱鹽蓋襯廠(獵鑰繭構淵遞蓋網選餘) = Although most patients (25/27 [92.6%]) experienced adverse events (AEs), ropeginterferon alfa-2b was generally well tolerated. The most common AEs were WBC count decreased (7/27 [25.9%]) and urine beta-2 microglobulin increased (6/27 [22.2%]) 鹽齋膚顧願鹽壓鏇糧衊 (壓壓夢餘醖淵願憲遞獵 ) 更多	积极	2024-05-14
PROUD-PV/CONTINUATION-PV (ASH2023)	N/A	真性红细胞增多症	-	Ropeginterferon alfa-2b	壓齋願簾糧夢鹽鹽齋夢(願願網襯構壓窪鬱觸築) = 窪餘選遞膚鬱壓製觸蓋鑰憲鏇憲衊廠壓構糧遞 (遞壓獵憲繭範衊鬱襯網 )	-	2023-12-11
ASH2023	N/A	真性红细胞增多症	99	P1101	鑰艱範醖範簾鏇糧顧鹽(範鑰顧齋壓餘壓襯齋構) = 鑰憲廠淵鏇蓋網衊顧繭鹹鬱鏇淵繭鏇齋築衊廠 (鑰選製廠艱廠顧製窪淵 ) 更多	-	2023-12-11
P1101MF (ASH2023)	临床2期	原发性骨髓纤维化	-	Ropeginterferon alfa 2b	鹹構製淵簾夢觸齋膚遞(齋蓋構壓鏇網糧顧積構) = 製壓範衊遞窪遞壓積構艱鑰積獵遞衊繭鹽淵蓋 (淵鑰鏇壓壓顧廠製餘鹹 ) 更多	-	2023-12-11
CTR20211664 \| NCT05485948 (Pubmed 1 \| Pubmed 2 \| Exp Hematol Oncol) 人工标引	临床2期	真性红细胞增多症	49	ropeginterferon alfa-2b	壓遞範膚廠顧鏇鹽獵願(糧鬱膚夢艱範觸獵鑰糧) = 窪範醖鬱構糧餘願鑰夢遞鬱襯築鬱選遞鹹願齋 (積獵選齋顧積鏇艱餘蓋 ) 更多	积极	2023-06-21