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A Study of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Previously Untreated Primary Immune Thrombocytopenia (ITP) (ROMISTER)

2026年9月15日 更新者：Amgen

A Phase 3, Randomized, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Romiplostim Plus Predniso(lo)ne vs. Predniso(lo)ne Alone for the Treatment of Adults With Previously Untreated Primary Immune Thrombocytopenia (ITP).

This Phase 3 study is designed to evaluate the efficacy and safety of romiplostim in combination with predniso(lo)ne compared with predniso(lo)ne alone in adults with previously untreated Primary Immune Thrombocytopenia (ITP).

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

126

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 美国
    • California
      • Long Beach、California、美国、90806
        • 招聘中
        • MemorialCare Long Beach Medical Center
    • Illinois
      • Peoria、Illinois、美国、61614
        • 招聘中
        • The Bleeding and Clotting Disorders Institute
    • Virginia
      • Fredericksburg、Virginia、美国、22408
        • 招聘中
        • Hematology Oncology Associates of Fredericksburg

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Age ≥18 years or adult legal age within country if older than 18 years.

  • Diagnosis of primary ITP according to the 2019 International Consensus (ICR) that is previously untreated and requires treatment.

    • Note: The investigator should ensure that the diagnosis of primary ITP is established by excluding other causes of isolated thrombocytopenia, as outlined in the 2019 ICR, which states that the diagnosis of primary ITP is principally based on the exclusion of other causes of isolated thrombocytopenia.
    • Note: If emergency treatment is necessary, platelet count performed before emergency can be used for study inclusion.
    • Note: Emergency ITP treatment with any thrombopoietin receptor agonists (TPO-RAs), or splenectomy is not allowed.
  • Platelet count < 30 × 10^9/L or Platelet count < 50× 10^9/L with clinically significant bleeding before any medical intervention.

Exclusion Criteria:

  • Life-threatening bleeding at randomization.
  • Known sensitivity or intolerance to any of the products to be administered during study (eg, uncontrolled diabetes) or to any Escherichia coli-derived product (eg, filgrastim, pegfilgrastim, certain insulins).
  • Uncontrolled hypertension before randomization.
  • Abnormal hepatic or renal function at screening.
  • History of total splenectomy.
  • Use of concurrent anticoagulation therapy and/or antiplatelet therapy.
  • Need for nonsteroidal anti-inflammatory drugs (NSAIDs) use and use of NSAIDs within 7 days before randomization.
  • Venous or arterial thrombotic event within 3 or 6 months, respectively, before randomization.
  • Other protocol-defined Inclusion/Exclusion may apply.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Romiplostim + Predniso(lo)ne

Participants will receive romiplostim administered subcutaneously (SC) in combination with predniso(lo)ne administered orally during Part 1 of the study.

Participants who complete Part 1 of the study will enter Part 2 and continue participation for study assessments.
药品：Romiplostim
Administered subcutaneously.
其他名称：
  • Nplate®
  • AMG 531
药品：Predniso(lo)ne
Administered orally.
有源比较器：Predniso(lo)ne

Participants will receive predniso(lo)ne administered orally during Part 1 of the study.

Participants who complete Part 1 of the study will enter Part 2 and continue participation for study assessments.
药品：Predniso(lo)ne
Administered orally.

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Percentage of Participants With a Durable Platelet Response (DPR)
大体时间：8 weeks
8 weeks

次要结果测量

结果测量
大体时间
Time to Next Treatment (TTNT)
大体时间：12 months
12 months
Cumulative Exposure to Corticosteroids
大体时间：12 months
12 months
Change From Baseline in ITP Patient Assessment Questionnaire (ITP-PAQ)
大体时间：12 months
12 months
Change in Summary Scores and Visual Analogue Scale (VAS) Scores per EuroQol 5-Dimension 5-Level (EQ 5D-5L)
大体时间：12 months
12 months
Incidence of Hospitalization and Rescue Medication in Part 1
大体时间：6 months
6 months
Number of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs), Treatment-Emergent Adverse Events of Interest (EOI), and Fatal TEAEs
大体时间：12 months
12 months
Percentage of Participants With Clinically Significant Bleeding Events in the Immune Thrombocytopenia-specific Bleeding Assessment Tool (ITP-BAT)
大体时间：6 months
6 months
Serum Trough Concentration (Ctrough) of Romiplostim
大体时间：6 months
6 months
Number of Participants With Anti-Romiplostim Antibodies and Anti-Thrombopoietin (TPO) Antibodies
大体时间：6 months
6 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Amgen

调查人员

  • 研究主任：MD、Amgen

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年8月21日

初级完成 (估计的)

2029年9月14日

研究完成 (估计的)

2029年10月14日

研究注册日期

首次提交

2026年7月7日

首先提交符合 QC 标准的

2026年7月7日

首次发布 (实际的)

2026年7月13日

研究记录更新

最后更新发布 (实际的)

2026年9月17日

上次提交的符合 QC 标准的更新

2026年9月15日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 20250124

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD 共享时间框架

Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.

IPD 共享访问标准

Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 国际碳纤维联合会
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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