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A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)
NCT07001280 · View on ClinicalTrials.gov ↗
Study Summary
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.
Conditions Studied
Interventions
- OTHER No intervention
Study Locations (9)
Arizona
- Medical Research of Arizona — Phoenix
Maryland
- John Hopkins University — Baltimore
Missouri
- Washington University — St Louis
New Jersey
- Riverside Medical Group, Belleville — Belleville
Hesse
- HZRM Haemophilie-Zentrum Rhein Main — Frankfurt am Main
Lower Saxony
- Medizinische Hochschule Hannover — Hanover
Saxony
- Universitaetsklinikum Carl Gustav Carus TU Dresden — Leipzig
Schleswig-Holstein
- Universitaetsklinikum Schleswig Holstein - Campus Luebeck — Hamburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2025-07-21 |
| Est. Completion | 2030-08-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07001280
The ClinicalTrials.gov registry entry for NCT07001280 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is CSL Behring, which has 85 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hereditary Angioedemas appearing as the primary indexed condition, and to 1 intervention — of which No intervention is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07001280 reports 9 study locations spanning 9 distinct geographic areas — top geographies include Arizona, Maryland, Missouri. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT07001280 about?
NCT07001280 is a clinical study titled "A Study Investigating the Effectiveness and Safety of Garadacimab for Treating Patients With Hereditary Angioedema (HAE)". 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...
What is the current status of trial NCT07001280?
This trial is currently recruiting. The enrollment target is 200 participants. The study started on 2025-07-21. Estimated completion is 2030-08-31.
What conditions does trial NCT07001280 study?
This clinical trial studies the following conditions: Hereditary Angioedemas. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07001280?
The interventions under investigation include: No intervention (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07001280?
This trial is sponsored by CSL Behring, which has 85 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07001280 being conducted?
This trial has 9 study locations across Arizona, Maryland, Missouri, New Jersey, Hesse. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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