jRCT2041260092进行中（未招募）不适用
An open-label, nonrandomized, multicenter extension study to evaluate the long-term safety and efficacy of Pegcetacoplan in participants with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
未提供0 个研究点目标入组 3 人开始时间: 待定
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
入排标准
- 年龄范围
- 12age old over 至 No limit（—）
- 性别
- All
入选标准
- •Participants must have completed participation in Study APL2-C3G-310 through the week 52 visit requirements.
- •Participants must have experienced clinical benefit from Pegcetacoplan while participating in the previous trial, in the opinion of the investigator.
- •Participants must remain on a stable regimen for C3G or IC-MPGN treatment according to the requirements of Study APL2-C3G-
- •Participants must have received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) according to the requirements of Study APL2-C3G-310 and agree to receive any additional vaccinations recommended according to ACIP recommendations for adults or children with complement deficiencies and/or immunocompromising conditions or other similar local applicable guidelines.
- •Female participants of childbearing potential, defined as any woman who has experienced menarche and who is not permanently sterile or postmenopausal, must have a negative urine pregnancy test at visit 1 and must agree to use protocol-defined methods of contraception for the duration of the study through at least 90 days after receiving the last dose of Pegcetacoplan.
- •Male participants must agree to use protocol-defined methods of contraception and agree to refrain from donating semen for the duration of the study through at least 90 days after receiving the last dose of Pegcetacoplan.
- •Participants above the legal age of consent, in accordance with local regulations, must be willing and able to provide informed consent. The legally authorized representative of participants under the legal age of consent must be willing and able to provide informed consent; where appropriate, participants under the legal age of consent must also give their assent to participation in the study.
- •Participants must be willing and able to self-administer Pegcetacoplan or have an identified caregiver who can perform the administration.
排除标准
- •Female participants who are or are planning to become pregnant or who are currently breastfeeding and are unwilling to discontinue for the duration of the study and for at least 90 days after the final dose of study drug
- •Inability or unwillingness to cooperate with the requirements of the protocol
- •Any condition that, in the opinion of the investigator, creates an undue risk for the participant by participating in the study or is likely to confound interpretation of the study results
- •Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator
研究者
相似试验
尚未招募
不适用
An open-label extension (OLE) trial to evaluate long-term safety and tolerability of pelacarsen (TQJ230) (CTQJ230A12301E1)patients with established cardiovascular disease and elevated Lp(a)jRCT2031260071100
招募中
不适用
CEVOSTAMAB IN COMBINATION WITH POMALIDOMIDE AND DEXAMETHASONE VERSUS STANDARD OF CARE IN PATIENTS WITH PREVIOUSLY TREATED MULTIPLE MYELOMA2-4 Line Relapse / Refractory Multiple MyelomajRCT2041260039380
招募中
不适用
A CLINICAL STUDY TO EVALUATE THE EFFECTS OF NXT007 COMPARED TO EMICIZUMAB PROPHYLAXIS IN PEOPLE WITH HEMOPHILIA AHemophilia-AjRCT2051250252360
招募中
不适用
Study of Olverembatinib (HQP1351) in Patients With CP-CML (POLARIS-2)jRCT2051260072333
招募中
不适用
A First-in-human Study to Learn About the Safety of BAY 3547926 and How Well it Works in Participants With Advanced Liver CancerHepatocellular CarcinomajRCT2031260213148