Trial · NCT04057131
FIRAZYR General Drug Use-Results Survey (Japan)
NCT04057131, Completed, Shire; results first posted 2025-02-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. FIRAZYR General Drug Use-Results Survey (Japan). Trials, record NCT04057131. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04057131
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- FIRAZYR General Drug Use-Results Survey (Japan)
- NCT number
- NCT04057131
- Status
- Completed
- Enrollment
- 179 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- Firazyr
- First posted
- 2019-08-15
- Last updated
- 2025-02-21
- Results first posted
- 2025-02-21
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Baseline up to end of the study (up to approximately 68 months) | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Primary | Number of Participants With Adverse Drug Reaction | Baseline up to end of the study (up to approximately 68 months) | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. Adverse drug reaction refers to AE related to administered drug. |
| Primary | Time to Treatment for Attack | Up to 3 months | Time to treatment for attack defined as the time between the onset of the attack and the first injection of treatment. Time to treatment for attack was assessed and reported. |
| Primary | Time to First Symptom Relief | Up to 3 months | Time to first symptom relief defined as the time between the first injection of treatment and first symptom relief. Time to first symptom relief was assessed and reported. |
| Primary | Time to Complete Resolution of Attack | Up to 3 months | Time to complete resolution of attack defined as the time between the first injection of treatment and the complete resolution of all symptoms. Time to complete resolution of attack was assessed and reported. |
| Primary | Total Duration of Attack | Up to 3 months | Total duration of attack defined as the time between the onset of the attack and the complete resolution of all symptoms. Total duration of attack was assessed and reported. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events | Baseline up to end of the study (up to approximately 68 months) | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Adverse Drug Reaction | Baseline up to end of the study (up to approximately 68 months) | Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time to Treatment for Attack | Up to 3 months | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. | minutes | MEDIAN |
| PRIMARY | Time to First Symptom Relief | Up to 3 months | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. | minutes | MEDIAN |
| PRIMARY | Time to Complete Resolution of Attack | Up to 3 months | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. | minutes | MEDIAN |
| PRIMARY | Total Duration of Attack | Up to 3 months | Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. | minutes | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events | Icatibant Acetate Subcutaneous Infusion | 22 | Participants | ||
| Number of Participants With Adverse Drug Reaction | Icatibant Acetate Subcutaneous Infusion | 19 | Participants | ||
| Time to Treatment for Attack | Icatibant Acetate Subcutaneous Infusion | 120.0 | Inter-Quartile Range 30.0 to 360.0 | minutes | |
| Time to First Symptom Relief | Icatibant Acetate Subcutaneous Infusion | 60.0 | Inter-Quartile Range 30.0 to 450.0 | minutes | |
| Time to Complete Resolution of Attack | Icatibant Acetate Subcutaneous Infusion | 780.0 | Inter-Quartile Range 210.0 to 1800.0 | minutes | |
| Total Duration of Attack | Icatibant Acetate Subcutaneous Infusion | 1425.0 | Inter-Quartile Range 420.0 to 2880.0 | minutes |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Icatibant Acetate Subcutaneous Infusion | 179 | |
| Overall Study | COMPLETED | Icatibant Acetate Subcutaneous Infusion | 155 | |
| Overall Study | NOT COMPLETED | Icatibant Acetate Subcutaneous Infusion | 24 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Injection site pain | General disorders | Icatibant Acetate Subcutaneous Infusion | 7 | 155 | |
| serious | Facial bones fracture | Injury, poisoning and procedural complications | Icatibant Acetate Subcutaneous Infusion | 1 | 155 | |
| serious | Injury | Injury, poisoning and procedural complications | Icatibant Acetate Subcutaneous Infusion | 1 | 155 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Icatibant Acetate Subcutaneous Infusion | 0 | 155 |
| Total, other adverse events | Icatibant Acetate Subcutaneous Infusion | 7 | 155 |
| Total, serious adverse events | Icatibant Acetate Subcutaneous Infusion | 1 | 155 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42630033 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04057131
GET https://conductscience.org/api/trials/v1/NCT04057131/registered