New drug offers hope for rare swelling disorder patients
NCT ID NCT07290855
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a drug called icatibant (Icanticure) in 5 adults with a rare condition that causes sudden, painful swelling attacks. The goal was to see how quickly the drug relieved symptoms and if it was safe. Participants received the injection for free during an acute attack, and researchers tracked their pain and swelling relief over time.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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5 people
The number who actually took part.
- Started
-
Sep 2024
- Finished
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Sep 2025
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. The male or female patient is ≥20 years old at the time of informed consent. 2. The informed consent form has been read, signed and dated by the patient. 3. At the screening visit, the investigator diagnosed bradykinin-induced angioedema based on at least one of the following: * Recurrent attacks of edema and/or poor respond to antihistamines, corticosteroids or epinephrine * Recurrent angioedema attacks of abdominal, and/or laryngeal (inclusive of laryngeal and pharyngeal) areas * Angioedema without the presence of urticarial rashes * Known family history of angioedema * Known to have genetic defects related to hereditary angioedema 4. Able to communicate well with the investigator, comply with study questionnaires, and other instruments used for collecting patient-reported outcomes. Exclusion Criteria: 1. Known with a history of allergy or hypersensitivity to the investigational drug as judged by the investigator at the screening visit. 2. The patient has a diagnosis of angioedema other than bradykinin induced angioedema. 3. The patient has participated in another clinical study within the past 30 days before screening. 4. 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. The definitions of out of the reference ranges are: * Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), or alkaline phosphatase (ALP) \> 2.5 times ULN (Upper Limit Normal); * Serum total bilirubin \>= 1.5 times ULN; 5. 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. The definitions of out of the reference ranges are: * Creatinine clearance rate (\<= 40 mL/min) (estimated by Cockcroft-Gault formula) and serum creatinine \>=1.5 times ULN; * Blood urea nitrogen value \>= 1.5 times ULN 6. Presence of impaired hematological or coagulation functions as indicated by abnormal measure values, if any one of them is out of the reference range. 7. Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease. 8. Congestive heart failure (NYHA Class 3 and 4). 9. Stroke within the past 6 months. 10. Known pregnancy and/or breast-feeding. 11. In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study. 12. In the opinion of the investigator: unlikely to comply with the protocol, for example, uncooperative attitude, inability to return for follow-up visits, or unlikely to complete the study for any reason. 13. In the opinion of the investigator: inability to manage study medication or self-administration of an injection.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Taichung Veterans General Hospital
Taichung, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New RNA drug shows promise in preventing HAE attacks in ongoing study
- New drug TAKHZYRO tracked for Long-Term safety in rare swelling disorder