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临床试验/2025-524487-37-00
2025-524487-37-00招募中4 期

Real-World Effectiveness and Safety of Pegcetacoplan in Patients with C3 Glomerulopathy (C3G) or Primary Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN): A Multi-Country Study (PRISMC3)

Swedish Orphan Biovitrum AB (publ)70 个研究点 分布在 5 个国家目标入组 69 人开始时间: 2026年9月30日最近更新:
干预措施

试验速览

阶段
4 期
状态
招募中
入组人数
69
试验地点
70

研究概览

简要总结

To describe the real-world clinical effectiveness of pegcetacoplan in participants with C3G or primary IC-MPGN.

研究设计

分配方式
Na
主要目的
Treatment
盲法
None

入排标准

年龄范围
0 years 至 65+ years(65+ Years, 0-17 Years, 18-64 Years)
接受健康志愿者

入选标准

  • Have received or plan to receive pegcetacoplan for the treatment of C3G or primary IC-MPGN.
  • Provided signed and dated informed consent. For participants under the legal age signed and dated informed consent is provided by the participant’s legally authorised representative. Assent will also be obtained from paediatric participants as required by local regulations.

排除标准

  • Receiving an investigational treatment for C3G or primary IC-MPGN at the time of pegcetacoplan initiation.
  • Initiated treatment with pegcetacoplan in an interventional study.

研究组 & 干预措施

ASPAVELI 1 080 mg solution for infusion, ASPAVELI 1 080 mg solution for infusion

Test

干预措施: ASPAVELI 1 080 mg solution for infusion (Drug)

研究者

申办方类型
Pharmaceutical company
责任方
Principal Investigator
主要研究者

Study Physician

Scientific

Swedish Orphan Biovitrum AB (publ)

研究点 (70)

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