NCT07263685

A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) in the Kingdom of Saudi Arabia

StatusCompleted

PhaseNot specified

SponsorTakeda

Primary completionNov 3, 2026

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 9 versions: 9 with changes below. See every version on ClinicalTrials.gov ↗

Notable Nov 4, 2026 Eligibility criteria expanded, about 7 words Show 5 more changesShow less
- Trial completed
- Enrollment target: estimated 50 to confirmed 47
- Primary and study completion dates changed from estimate of Oct 30, 2026 to Nov 3, 2026
- Secondary endpoints: details revised at 3 of 3 entries
- Site details revised
Notable May 6, 2026 Recruitment opened
- Site details revised
v8
Minor Apr 28, 2026 Primary and study completion pushed from May 31, 2026 to Oct 30, 2026v7
Minor Apr 20, 2026 Start date: Apr 15, 2026 to Apr 30, 2026v6
Notable Mar 11, 2026 Start date: Mar 15, 2026 to Apr 15, 2026v5

Show 3 earlier versionsHide 3 earlier versions

Notable Feb 23, 2026 Start date: Jan 15, 2026 to Mar 15, 2026v4
Dec 23, 2025 Study Status, Referencesv3
Notable Dec 12, 2025 Start date: Dec 1, 2025 to Jan 15, 2026v2

Nov 24, 2025 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Change in HAE- Activity Score (AS) From Pre to Post Index Period

Timeframe: Up to 6 Months

Secondary (3)

Change in Quality of Life (QoL) Scores From Pre to Post Index Period

Change in HAE-C1INH Attack Frequency (number/month) From Pre to Post Index Period

Number of Participants Categorized by Demographic and Clinical Predictors of Treatment Response

Arms and interventions

Participants with HAE-C1INH-Type 1 or HAE-C1INH-Type 2

All participants diagnosed with HAE-C1INH type 1 or type 2 will be included, and retrospective clinical data will be collected from patient medical records between 01 September 2025 and 28 February 2026. Participants who received Takhzyro® during the eligibility period beginning in 2021 will be observed across two periods: a pre-index period, defined as the time before the first dose of Takhzyro® (index date), used to establish baseline characteristics and disease activity, and a post-index period, defined as at least 6 months following the index date, used to assess treatment outcomes. The index date is defined as the date of the first Takhzyro® administration during the eligibility period.

Other: No intervention

Sites

1 site in 1 country

King Faisal Specialist Hospital and Research CentreRiyadh, Saudi Arabia

About this trial

Hereditary angioedema (HAE) is a rare condition. It causes sudden swelling under the skin and inside the body, like in the belly, throat, or genitals. This swelling happens because of a temporary leak in blood vessels but does not cause itching or hives. HAE is classified based on the amount of a protein in the blood called C1 inhibitor (C1INH): HAE with normal C1INH levels (HAE-nC1INH) and HAE with limited or insufficient C1INH levels (HAE-C1INH); HAE-C1INH can be divided into Type 1, with low levels of C1INH, and Type 2, in which the protein is there, but does not work properly. This study will concentrate on people with HAE-C1INH Type 1 or 2 who have received Takhzyro® (lanadelumab) as prophylactic treatment for at least half a year (6 months). Prophylactic means that treatment is given to prevent the happening of HAE attacks. The main goal of the study is to see how well Takhzyro® works in everyday life to reduce the condition's activity after 6 months of treatment, or 12 months (if data is available). This will be measured by checking the change of the HAE activity from before treatment to after 6 months of treatment. The study design will permit a study follow-up of up to 12 months following the index event (i.e. date of first dose administration of Takhzyro®) unless the patient discontinues the index treatment, dies or is lost to follow-up within this timeframe. Chart abstractions will only occur once patients have at least 6 months' duration between the index event date and the date of chart abstraction initiation. Other goals are to find out how a person's quality of life changes after using Takhzyro® for 6 months, how often they had attacks before and after treatment and to learn which factors may have an impact on the treatment. The study will only look at data already existing in the participants' medical records. No treatment will be given as part of the study.

Trial details

Enrollment: 47 participants (actual)
Started: Apr 30, 2026
Study completion: Nov 3, 2026
Eligibility: 12 and older, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Angioedemas, Hereditary, Hereditary Angioedema (HAE)
Official title: 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)
First posted: Dec 4, 2025
Registry updated: Nov 9, 2026
Last verified: Nov 2026

Related trials at risk

View on ClinicalTrials.gov ↗