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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

Study acronym: VALE
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Site details revised at 1 of 47 sitesv6
  2. Minor Re-verified, no change to tracked fieldsv5
  3. Minor Study sites: 26 to 47v4
  4. Minor Trial status: Not Yet Recruiting to Active, Not Recruiting Study sites: 0 to 26 · Start date changed from estimate of May 2023 to May 29, 2023v3 Show 2 more changesShow less
    • Study sites: 0 to 26
    • Start date changed from estimate of May 2023 to May 29, 2023
  5. Minor Re-verified, no change to tracked fieldsv2
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05809531
Lead Sponsor Apellis Pharmaceuticals, Inc.
Conditions C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G), Complement 3 Glomerulonephritis, Dense Deposit Disease +4 more
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov