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Active (not recruiting) Phase 3 NCT05809531

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

Phase 3 – large-scale trial before approval
Conditions: C3G IC-MPGN C3 Glomerulopathy C3 Glomerulonephritis Complement 3 Glomerulopathy Complement 3 Glomerulopathy (C3G) Complement 3 Glomerulonephritis Dense Deposit Disease DDD Membranoproliferative Glomerulonephritis Membranoproliferative Glomerulonephritis (MPGN) Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

Sponsor: Apellis Pharmaceuticals, Inc.

trial.available_in: БГ
Overview
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).
Who can participate
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Locations 15
Argentina (1)
Hospital Privado-Universitario de Cordoba (54004)
Córdoba
Australia (1)
Kidney Trials Unit, Princess Alexandra Hospital (61007)
Woolloongab , Queensland
Belgium (1)
Catholic University of Leuven (32001)
Leuven
Brazil (1)
Santa Casa de Misericordia de Belo Horizonte (55017)
Belo Horizonte , Minas Gerais
Czech Republic (1)
Institute for Clinical and Experimental Medicine (42001)
Prague
France (1)
CHU de Bordeaux - Hopital Pellegrin (33010)
Bordeaux
Israel (1)
Schneider Childrens Medical Center (97204)
Petah Tikva
Italy (1)
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (39004)
Milan
Japan (1)
Nagasaki University Hospital (81005)
Nagasaki , Nagasaki
Netherlands (1)
AMC Apotheek Goederenontvangst (31002)
Amsterdam
South Korea (1)
Yonsei University College of Medicine, Sinchon Severance Hospital (82002)
Seoul
Spain (1)
Hosp. Universit. Materno-Infantil Vall d' Hebron (34006)
Barcelona
Switzerland (1)
CHUV Lausanne (41002)
Lausanne
United Kingdom (1)
Imperial College Hammersmith Hospital (44013)
London
United States (1)
Academic Medical Research Institute (01034)
Los Angeles , California
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
12 Years
Healthy volunteers
No
Start date
29.05.2023
Completion date
01.07.2027
Registry ID
NCT05809531
Source
anzctr
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