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Lanadelumab to prevent HAE attacks in children

A Multi-national Real-world Outcomes and Treatment Patterns Study of Lanadelumab (Takhzyro) in Paediatric Patients With Hereditary Angioedema (TAHORA)

Observational Takeda · NCT07251933

This project will try lanadelumab as a regular preventive treatment for children aged 2 to 11 with HAE due to C1‑INH deficiency to see how long they remain attack-free in routine care.

Quick facts

Study typeObservational
Enrollment40 (estimated)
Ages2 Years to 11 Years
SexAll
SponsorTakeda Industry-sponsored
Drugs / interventionslanadelumab
Locations24 sites (La Plata, Buenos Aires and 23 other locations)
Trial IDNCT07251933 on ClinicalTrials.gov

What this trial studies

This observational, multicenter study collects real-world medical record data on children aged 2 to less than 12 who started long-term prophylaxis with lanadelumab for HAE due to C1‑INH deficiency. Researchers will measure attack frequency and the time children remain free of HAE attacks after starting lanadelumab, and will record treatment patterns and safety events. No interventional changes are made for the purpose of the study; care is as provided by the treating physicians. Sites are pediatric centers in Buenos Aires, Argentina, and follow-up is expected for at least six months or until the child turns 12.

Who should consider this trial

Good fit: Children aged 2 to less than 12 with a physician-confirmed diagnosis of HAE due to C1‑INH deficiency who have initiated lanadelumab prophylaxis and have medical records documenting attacks before and after starting treatment.

Not a fit: Children without documented HAE attacks in the 12 months before starting lanadelumab, those with HAE with normal C1‑INH, or those enrolled in other investigational drug trials are unlikely to benefit from or be eligible for this observational project.

Why it matters

Potential benefit: If successful, the study could show that lanadelumab helps children with HAE‑C1INH stay attack-free longer in everyday clinical practice, supporting safer and more effective preventive care.

How similar studies have performed: Lanadelumab has previously reduced HAE attack rates in adolescents and adults in clinical trials, but systematic real-world data in young children are limited.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Participant is aged 2 to less than (\<) 12 years at the time of lanadelumab initiation and is expected to have at least 6 months of follow-up information before turning 12.
2. Participant has physician-confirmed diagnosis of HAE-C1INH.
3. Participant initiated LTP with lanadelumab during the eligibility period.
4. Signed consent/assent (where required by local regulations).
5. Participant's medical record contains documentation of HAE attacks in the pre-index period and after lanadelumab initiation.

Exclusion Criteria:

1. Participant was enrolled in a therapeutic investigational drug (lanadelumab or other drug) or device trial at index date.
2. Participant with no documented HAE attacks in the 12 months prior to index date.

Where this trial is running

La Plata, Buenos Aires and 23 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hereditary AngioedemaDrug Therapy
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.