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Clinical Trial ● Currently Recruiting NCT07001280

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

A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE) — Recruiting • Cardiology / Cardiovascular • NCT07001280.

📅 03 Jun 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
NCT ID
NCT07001280
Sponsor
CSL Behring
Start
2025-07-21
ClinicaliQ Trial Snapshot
  • A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE) — Recruiting • Cardiology / Cardiovascular • NCT07001280.
  • Treatment being tested: Garadacimab effectiveness and safety in real-world clinical practice for hereditary angioedema (HAE) management, with long-term follow-up data collected over 48 months in routine NHS and international healthcare settings.
  • Patient eligibility: Adults with confirmed HAE who are newly starting garadacimab treatment in standard clinical practice, representing the broader patient population beyond controlled trial conditions.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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…

Eligibility Snapshot
  • : *
  • Participants aged greater than or equal to (>=) 12 years at enrollment. *
  • Participants with clinical and/or laboratory confirmed diagnosis of HAE. *
  • Participants newly initiating garadacimab, as prescribed according to the decision of the treating physician per routine clinical practice and in accordance with the indication per the approved local label, independent of and prior to enrollment in the study. * 4. Willing and able to provide written informed consent and/or assent by parent or legal guardian for children less than (

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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