NCT06818474 Lanadelumab in Long-term Prophylaxis of Acquired Angioedema
| NCT ID | NCT06818474 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Bernstein Clinical Research Center |
| Condition | Angioedema |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 5 participants in total. It began in 2024-06-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
use of lanadelumab in patients with acquired angioedema
Eligibility Criteria
Inclusion Criteria: * A diagnosis of AAE with recurrent attacks without urticaria (decreased C1INH functional, quantitative levels, decreased C4 and decreased C1q levels, no family history of angioedema), presence of anti-C1INH antibody and/or paraproteinemia (e.g. monoclonal gammopathy of unknown significance) * historical attack rate of \>= on attack per month prior to starting tranexamic acid (TAA) Exclusion Criteria: * History of anaphylaxis or hypersensitivity to biologics * History of major systemic disease not well controlled in opinion of the PI * Women who are pregnant or breast feeding * Concurrent participation in other clinical trials * HAE Type 1 or 2 and normal complement HAE
Contact & Investigator
Jonathan Bernstein, MD
PRINCIPAL INVESTIGATOR
5139314181
Frequently Asked Questions
Who can join the NCT06818474 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Angioedema. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06818474 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06818474 currently recruiting?
Yes, NCT06818474 is actively recruiting participants. Contact the research team at kberendts@bernsteincrc.com for enrollment information.
Where is the NCT06818474 trial being conducted?
This trial is being conducted at Cincinnati, United States.
Who is sponsoring the NCT06818474 clinical trial?
NCT06818474 is sponsored by Bernstein Clinical Research Center. The principal investigator is Jonathan Bernstein, MD at 5139314181. The trial plans to enroll 5 participants.