A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angiā¦ (NCT07290855) | Clinical Trial Compass
CompletedPhase 4
A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema
Taiwan5 participantsStarted 2024-09-27
Plain-language 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 (IcanticureĀ®).
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 IcanticureĀ® 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 IcanticureĀ® to meet their clinical urgent needs. The safety and efficacy of IcanticureĀ® are evaluated by the prospective, planed assessments in the enrolled patients.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
ā. The male or female patient is ā„20 years old at the time of informed consent.
ā. The informed consent form has been read, signed and dated by the patient.
ā. At the screening visit, the investigator diagnosed bradykinin-induced angioedema based on at least one of the following:
ā. Able to communicate well with the investigator, comply with study questionnaires, and other instruments used for collecting patient-reported outcomes.
Exclusion criteria
ā. Known with a history of allergy or hypersensitivity to the investigational drug as judged by the investigator at the screening visit.
ā. The patient has a diagnosis of angioedema other than bradykinin induced angioedema.
ā. The patient has participated in another clinical study within the past 30 days before screening.
ā. Presence of liver disease or liver injury as indicated by an abnormal liver function profile such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), or total bilirubin, if any one of them is out of the reference range.
What they're measuring
1
To evaluate the time to complete or near complete resolution from onset of symptoms
Timeframe: Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours
ā. Presence of impaired renal function as indicated by abnormal creatinine or blood urea nitrogen values, if any one of them is out of the reference range.
ā. Presence of impaired hematological or coagulation functions as indicated by abnormal measure values, if any one of them is out of the reference range.
ā. Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease.
ā. Congestive heart failure (NYHA Class 3 and 4).