Actively Recruiting
Retrospective Chart Review Evaluating Lanadelumab's Effectiveness and Quality of Life Impact in Teenagers and Adults With Hereditary Angioedema in Saudi Arabia
Led by Takeda · Updated on 2026-05-11
50
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Hereditary angioedema (HAE) is a rare condition causing sudden swelling under the skin and inside the body, such as in the belly, throat, or genitals. This swelling is due to temporary blood vessel leaks and does not cause itching or hives. The study focuses on people with HAE-C1INH Type 1 or 2 who have been using Takhzyro4 (lanadelumab) to prevent HAE attacks, aiming to evaluate how well this treatment reduces disease activity in everyday life after 6 to 12 months of use. This observational study will collect retrospective clinical data from medical records for participants diagnosed with HAE-C1INH Type 1 or 2 who started long-term prophylaxis with Takhzyro4. Data from before the first Takhzyro4 dose (pre-index) and at least 6 months after the first dose (post-index) will be examined to assess treatment outcomes. No new treatment will be given as part of the study. Participants' medical records will be reviewed to track changes in HAE activity scores, quality of life, and attack frequency before and after treatment, with data collected between September 2025 and February 2026. The study will also explore factors affecting treatment response. Follow-up can last up to 12 months after the first Takhzyro4 dose unless treatment stops, the patient dies, or is lost to follow-up.
CONDITIONS
Brief Title
A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in the Kingdom of Saudi Arabia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with HAE-C1INH Type 1 or Type 2 and started long-term prophylaxis with Takhzyro (lanadelumab).
- Aged 12 years or older at the time of starting Takhzyro.
- Received continuous Takhzyro treatment for at least 6 months before data collection.
You will not qualify if you...
- Having normal C1INH function or HAE-nC1INH (formerly Type III HAE).
- Discontinued Takhzyro before completing 6 months of treatment.
- Incomplete medical records preventing assessment of HAE activity score before and after treatment.
- Participating in other interventional clinical trials involving HAE-C1INH treatments during the observation period.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants who started long-term prophylaxis with Takhzyro are observed retrospectively through their medical records to assess disease activity and treatment outcomes before and after starting Takhzyro.
Data collected retrospectively from medical records
Trial Site Locations
Total: 1 location
1
King Faisal Specialist Hospital and Research Centre
Riyadh, Saudi Arabia, 12713
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here