NCT05809531进行中（未招募）3 期
An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Patients With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 47
- 主要终点
- Proportion of participants with a reduction in urine protein-to-creatinine ratio (uPCR) of at least 50% from the pretreatment value over time.
研究概览
简要总结
This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed participation in Study APL2-C3G-310 through the week 52 visit requirements
- •Experienced clinical benefit from pegcetacoplan while participating in the previous trial, in the opinion of the investigator
- •Must remain on a stable regimen for C3G or IC-MPGN treatment according to the requirements of Study APL2-C3G-310
- •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
- •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
研究组 & 干预措施
Pegcetacoplan administered subcutaneously
Experimental
Pegcetacoplan administered subcutaneously twice weekly according to protocol defined dosing regimen
干预措施: Pegcetacoplan (Drug)
结局指标
主要结局
Proportion of participants with a reduction in urine protein-to-creatinine ratio (uPCR) of at least 50% from the pretreatment value over time.
时间窗: 2.5 years
次要结局
未报告次要终点
研究者
研究点 (47)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study in Participants Previously Enrolled in a Genentech- and/or F. Hoffmann-La Roche Ltd-Sponsored Atezolizumab Study (IMbrella A)CancerNCT03148418Hoffmann-La Roche382
终止
2 期
Open-Label Study to Evaluate the Long-Term Safety and Efficacy of VI-0521 in Type 2 Diabetic AdultsDiabetesNCT00737633VIVUS LLC101
已完成
4 期
Study Evaluating the Combination of Etanercept and Methotrexate in Rheumatoid Arthritis SubjectsRheumatoid ArthritisNCT00252668Wyeth is now a wholly owned subsidiary of Pfizer300
终止
2 期
A Clinical Study to Test Long Term Safety of GLPG1690 for Patients With Systemic SclerosisSystemic SclerosisNCT03976648Galapagos NV31
终止
2 期
Guadecitabine Extension StudyMyeloid Dysplastic SyndromeAcute Myeloid LeukemiaNCT03603964Astex Pharmaceuticals, Inc.35