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A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)

Study acronym: GREAT
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial sites expanded: 18 → 22 locationsv8
  2. Study sites: 9 to 18v7
  3. Study sites: 1 to 9 Eligibility criteria expanded, about 7 wordsv6 Show 1 more changeShow less
    • Eligibility criteria expanded, about 7 words

    See this version in full on ClinicalTrials.gov ↗

  4. Start date: Jul 26, 2025 to Jul 21, 2025v5
  5. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 30, 2025 to Jul 26, 2025v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 30, 2025 to Jul 26, 2025
Show 2 earlier versionsHide 2 earlier versions
  1. Start date: Jun 30, 2025 to Jul 30, 2025v3
  2. Start date: May 30, 2025 to Jun 30, 2025v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
CSL Behring
30 trials monitored
See 2 trials at risk
This is a multinational, multicenter, prospective, observational cohort study of patients with HAE in the real-world setting. The study will include patients newly initiating garadacimab in routine clinical practice. Each participant will be followed for 48 months after index date (date of the first administration of garadacimab). Patient data will be collected from the HAE eDiary, patient medical records (MRs) and/or during a routine clinical visit and will be entered into the electronic case report form (eCRF) via an electronic data capture (EDC) system. Data pertaining to HAE attacks, prior HAE treatments, retrospective focused safety data collection, and healthcare resource utilization (HCRU) over a look-back period of 12 months prior to the enrollment will be extracted from the MR, and patients will also record retrospective HAE attack related data over a look-back period of 3 months prior to enrollment in the HAE eDiary. The primary aim of this study is to investigate the real-world effectiveness of garadacimab as measured by HAE attack rate before and after garadacimab initiation in patients with HAE over 24 months of follow-up. The study will aim to complement the data available from the clinical development program on the efficacy, safety, and health-related quality-of-life (HRQoL) in patients with HAE taking garadacimab.
Trial Details
NCT Number NCT07001280
Lead Sponsor CSL Behring
Conditions Hereditary Angioedemas
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov