Evaluating the effects of lanadelumab and icatibant in patients with Hereditary Angioedema in China
The Real-World Effectiveness and Safety of Lanadelumab (Takhzyro) and Icatibant (Firazyr®) for Hereditary Angioedema: An Observational Study in China
This study looks at how often people in China with Hereditary Angioedema have attacks while using lanadelumab and how quickly icatibant helps treat those attacks.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 130 (estimated) |
| Sex | All |
| Sponsor | Takeda Industry-sponsored |
| Drugs / interventions | lanadelumab |
| Locations | 13 sites (Fuzhou, Fujan and 12 other locations) |
| Trial ID | NCT06346899 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the frequency of Hereditary Angioedema (HAE) attacks in Chinese patients receiving lanadelumab and to evaluate the resolution time of acute HAE attacks treated with icatibant. Participants will be those who have received at least one dose of either medication since their approval in China. The study will analyze existing medical records to gather data on treatment outcomes, side effects, and treatment adherence without any new interventions. The findings will help improve understanding of these treatments in routine clinical practice.
Who should consider this trial
Good fit: Ideal candidates include Chinese individuals aged 12 years and older who have received lanadelumab or icatibant.
Not a fit: Patients currently participating in other interventional studies involving HAE treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the management of Hereditary Angioedema by providing insights into treatment effectiveness and safety.
How similar studies have performed: Previous studies have shown positive outcomes with similar treatments for HAE, indicating a potential for success in this observational approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion criteria: * Chinese participants who have received at least one dose of lanadelumab or icatibant from the lanadelumab NMPA approval date (02-Dec-2020) to the date of the day before the 1st site initiation date. * Informed consent will be obtained from the participant (and/or a legally authorized representative) prior to including that participant as a study participant and accessing that participant's data, except for cases in which the informed consent can be waived by the site. Exclusion criteria: • Participation in other interventional studies involving lanadelumab, icatibant, or any other HAE drug or investigational product on or after the date of the participant's lanadelumab or icatibant initiation.
Where this trial is running
Fuzhou, Fujan and 12 other locations
- The First Affiliated Hospital of Fujian Medical University — Fuzhou, Fujan, China (Recruiting)
- The First Affiliated Hospital ,Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, China (Recruiting)
- Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
- Tongji Hospital,Tongji Medical College,Huazhong University of Science & Technology — Wuhan, Hubei, China (Recruiting)
- The First Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
- Qianfo Mountain Hospital, Shandong Province — Jinan, Shandong, China (Recruiting)
- Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai, China (Recruiting)
- Shanxi Bethune hospital — Taiyuan, Shanxi, China (Recruiting)
- The Second Affiliated hospital of Xian Jiaotong University — Xian, Shanxi, China (Recruiting)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
- First Affiliated hospital of Kunming Medical University — Kunming, Yunnan, China (Recruiting)
- The Second Affiliated hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (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.