Lanadelumab for teenagers and adults with hereditary angioedema in Saudi Arabia
Retrospective Chart Review Study Evaluating Clinical Effectiveness and Impact on Quality of Life Among Patients Who Initiated Long-term Prophylaxis With Takhzyro® in a Real-World Setting in the Kingdom of Saudi Arabia - the REFLEQT-KSA Study (Retrospective Evaluation Focusing on Lanadelumab's Effectiveness and Impact on Quality of Life in The Kingdom of Saudi Arabia)
This project looks at how well lanadelumab (Takhzyro) prevents HAE attacks in teenagers and adults with C1‑INH deficiency who have been on the drug for at least six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | lanadelumab |
| Locations | 1 site (Riyadh) |
| Trial ID | NCT07263685 on ClinicalTrials.gov |
What this trial studies
This is an observational, record‑based project of teenagers and adults with HAE‑C1INH Type 1 or 2 who initiated lanadelumab prophylaxis and have at least six months of continuous treatment documented at a single center in Riyadh. Investigators will abstract baseline HAE activity scores and attack frequency from medical records at the time of lanadelumab initiation and again at six months (and 12 months when available). No new treatment is given; the analysis describes real‑world effectiveness and safety measures in routine clinical care. Outcomes will include changes in attack rates, HAE‑AS scores, and treatment patterns in this Saudi patient population.
Who should consider this trial
Good fit: Ideal candidates are people aged 12 or older with HAE‑C1INH Type 1 or 2 who started lanadelumab prophylaxis and have at least six months of continuous treatment recorded in their medical charts.
Not a fit: People with HAE‑nC1INH, those who stopped lanadelumab before six months, those lacking reliable medical records, or those enrolled in other interventional HAE trials would not benefit from this project.
Why it matters
Potential benefit: If successful, the results could show that lanadelumab reduces HAE attack frequency in routine clinical practice and support its continued use locally.
How similar studies have performed: Randomized trials and multiple real‑world reports have already shown that lanadelumab lowers attack rates in HAE‑C1INH patients, so this project builds on established evidence in a local population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant is diagnosed with HAE-C1INH-Type 1 or HAE-C1INH-Type 2 and initiated on long-term prophylaxis (LTP) with Takhzyro® (lanadelumab). 2. Participant is aged greater than or equal to (\>=) 12 years at the time of Takhzyro® initiation. 3. Participant has received at least 6 months of continuous treatment with Takhzyro® before data abstraction. Exclusion Criteria: 1. Participants who have normal C1INH function or HAE-nC1INH (formerly type III HAE). 2. Participants who discontinued Takhzyro® before completing 6 months of treatment. 3. Participants with insufficient or incomplete medical records which prevent the assessment of baseline HAE-AS at the time of Takhzyro® initiation, as well as 6 months HAE-AS after treatment initiation. 4. Participants who are participating in an interventional clinical trial involving other HAE-C1INH treatments during the observation period.
Where this trial is running
Riyadh
- King Faisal Specialist Hospital and Research Centre — Riyadh, Saudi Arabia (Recruiting)
Study contacts
- Study coordinator: Takeda Contact
- Email: medinfoUS@takeda.com
- Phone: +1-877-825-3327
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.