NCT07290855

A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema

A Phase IV Clinical Study of Evaluating the Safety and Efficacy of Icatibant Injection (Icanticure) in the Treatment of Patients With Bradykinin Induced Angioedema

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Nang Kuang Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This is a phase IV clinical study. The investigators collect patients with a diagnosis of bradykinin induced angioedema. For a specific study period and prospectively arrange, the eligible patients who has an acute attack of angioedema could be treated by icatibant Injection (Icanticure®). The drug, icatibant injection has been reimbursed by National Health Insurance Agency, Taiwan (NHI) in the treatment of diagnosed patients with hereditary angioedema. However, the reimbursement is still limited for some patients with atypical conditions. Therefore, Nang Kuang Company initiates a phase IV case collection study and supplies Icanticure® for free during the study period. Patients who still unable to obtain NHI's reimbursed icatibant drug is eligible for the inclusion, enter into the study and can be treated by Icanticure® to meet their clinical urgent needs. The safety and efficacy of Icanticure® are evaluated by the prospective, planed assessments in the enrolled patients.

Conditions

• Bradykinin-mediated Angioedema
• Hereditary Angioedema (HAE)

Interventions

Type	Name	Description
DRUG	Icatibant Injection (Icanticure®)	30 mg/3 ml injectable prefilled syringe for the treatment of acute attacks of hereditary angioedema (HAE) in children 2 years of age and older.

Timeline

• Start date: 2024-09-27
• Primary completion: 2025-05-27
• Completion: 2025-09-26
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: Taiwan