Bradykinin-mediated AngioedemaPhase 4NCT07290855
A Study to Evaluate the Safety and Efficacy of Icatibant in Patients With Bradykinin Induced Angioedema
A Phase 4 study testing Icatibant Injection (Icanticure®) in people with Bradykinin-mediated Angioedema and Hereditary Angioedema (HAE), run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
Trial 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®). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bradykinin-mediated Angioedema, Hereditary Angioedema (HAE)
- What is being tested?
- Icatibant Injection (Icanticure®)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteTaiwan
- Study dates
- 27 Sep 2024to 26 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The male or female patient is ≥20 years old at the time of informed consent.
- The informed consent form has been read, signed and dated by the patient.
- 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
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- Known family history of angioedema
- Known to have genetic defects related to hereditary angioedema
- Able to communicate well with the investigator, comply with study questionnaires, and other instruments used for collecting patient-reported outcomes.
Who cannot join
- Known with a history of allergy or hypersensitivity to the investigational drug as judged by the investigator at the screening visit.
- The patient has a diagnosis of angioedema other than bradykinin induced angioedema.
- The patient has participated in another clinical study within the past 30 days before screening.
- 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);
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- Serum total bilirubin >= 1.5 times ULN;
- 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
- Presence of impaired hematological or coagulation functions as indicated by abnormal measure values, if any one of them is out of the reference range.
- Evidence of symptomatic coronary artery disease based on medical history, in particular, unstable angina pectoris or severe coronary heart disease.
- Congestive heart failure (NYHA Class 3 and 4).
- Stroke within the past 6 months.
- Known pregnancy and/or breast-feeding.
- In the opinion of the investigator: mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study.
- 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.
- In the opinion of the investigator: inability to manage study medication or self-administration of an injection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase IV Clinical Study of Evaluating the Safety and Efficacy of Icatibant Injection (Icanticure) in the Treatment of Patients With Bradykinin Induced Angioedema
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.
- Being tested
- Icatibant Injection (Icanticure®)
- Medical subject headings
- Angioedemas, Hereditary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icatibant Injection (Icanticure®)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Icatibant Injection (Icanticure®) | Experimental | Not described Receives: Drug: Icatibant Injection (Icanticure®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the time to complete or near complete resolution from onset of symptoms
The time of onset of acute attack, the time of Icanticure® given, the time of onset of symptom relief, and the time to complete relief of symptoms will be recorded by the patient in minutes. Time to complete relief of symptoms is defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.
Measured: Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours
Secondary outcomes (3)
Percent Change in VAS pain score: VAS scale ranges from 0-10 with 0 being no any pain and 10 being the highest severity in pain
The VAS pain scores from 0-10 will be recorded by patients themselves on the following timing, the time of onset of acute attack, the time of Icanticure® given, the time of onset of symptom relief, and the time to complete relief of symptom.
Measured: The time from the onset of acute attack to the time to complete or near complete resolution of symptoms as reported by the patient. The estimated period of time is considered to up to 24 hours.
To evaluate volume change of edema from onset of symptoms to complete or near complete resolution.
Volume change of edema will be recorded by patients themselves by using a tape to measure millimeters of the edema part on the following timing, the time of onset of acute attack, the time of Icanticure® given, the time of onset of symptom relief, and the time to complete relief of symptom.
Measured: Volume change will be measured from the onset of acute attack to the time to complete or near complete resolution of symptoms as reported by the patient. The estimated period of time is considered to up to 24 hours
To evaluate the safety and tolerability: the safety profile of Icanticure® will be evaluated by the following parameters.
- Adverse events (AEs) incidence, but the adverse events are not included the pains related to angioedema symptoms which have been evaluated by the VAS pain scores.
- Local injection site reaction
Measured: At least 24 hours post-dose of Icanticure®
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study start27 Sep 2024
- Primary completion27 May 2025
- Study completion26 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bradykinin-mediated AngioedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07290855
- Sponsor's protocol ID
- NKC464-202301
- Status last verified
- Mar 2025
- First submitted
- 12 Mar 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV Clinical Study of Evaluating the Safety and Efficacy of Icatibant Injection (Icanticure) in the Treatment of Patients With Bradykinin Induced Angioedema
- ClinicalTrials.gov ID
- NCT07290855
- Acronym / sponsor ID
- NKC464-202301
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Nang Kuang Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- 27 May 2025 (actual)
- Study completion
- 26 Sep 2025 (actual)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Icatibant Injection (Icanticure®) | Experimental | Drug: Icatibant Injection (Icanticure®) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The male or female patient is ≥20 years old at the time of informed consent.
- The informed consent form has been read, signed and dated by the patient.
- At the screening visit, the investigator diagnosed bradykinin-induced angioedema based on at least one of the following:
- Able to communicate well with the investigator, comply with study questionnaires, and other instruments used for collecting patient-reported outcomes.
Key exclusion criteria (19 listed)
- Known with a history of allergy or hypersensitivity to the investigational drug as judged by the investigator at the screening visit.
- The patient has a diagnosis of angioedema other than bradykinin induced angioedema.
- The patient has participated in another clinical study within the past 30 days before screening.
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Icatibant Injection (Icanticure®) |
Primary outcome
To evaluate the time to complete or near complete resolution from onset of symptoms
Time frame: Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours
The time of onset of acute attack, the time of Icanticure® given, the time of onset of symptom relief, and the time to complete relief of symptoms will be recorded by the patient in minutes. Time to complete relief of symptoms is defined as time from onset of symptoms to complete or near complete resolution as reported by the patient.
3 secondary outcomes
Percent Change in VAS pain score: VAS scale ranges from 0-10 with 0 being no any pain and 10 being the highest severity in pain
Time frame: The time from the onset of acute attack to the time to complete or near complete resolution of symptoms as reported by the patient. The estimated period of time is considered to up to 24 hours.
To evaluate volume change of edema from onset of symptoms to complete or near complete resolution.
Time frame: Volume change will be measured from the onset of acute attack to the time to complete or near complete resolution of symptoms as reported by the patient. The estimated period of time is considered to up to 24 hours
To evaluate the safety and tolerability: the safety profile of Icanticure® will be evaluated by the following parameters.
Time frame: At least 24 hours post-dose of Icanticure®
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
Related trials for Bradykinin-mediated Angioedema
RecruitingPhase 1/2
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
Hereditary Angioedema (HAE), Angioedema
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Icatibant Injection (Icanticure®) in people with Bradykinin-mediated Angioedema and Hereditary Angioedema (HAE), run by Nang Kuang Pharmaceutical Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the time to complete or near complete resolution from onset of symptoms (time frame: Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.