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

Conditions

• Hereditary Angioedemas

Eligibility Criteria

Sex

ALL

Age

12 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• No intervention — OTHER
  No intervention will be administered as part of this study.

Study Details

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.

Key Dates

Start date

Jul 21, 2025

Status verified

May 2026

Primary completion

Aug 31, 2028

Completion

Aug 31, 2030

Study Design

Enrollment

200 participants (estimated)

Arms

• Arm: Garadacimab
  This cohort will include all participants diagnosed with HAE and who will be prescribed garadacimab treatment as per routine clinical practice.

Primary Outcome Measure

Incidence Rate Ratio (IRR) of HAE Attacks [ Time Frame: Up to 24 months ]

Central Contacts

• Trial Registration Coordinator
  +1 610-878-4697
  [email protected]

Locations (7)

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