Trial · NCT03888755
A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants
NCT03888755, Phase 3, Completed, Shire; results first posted 2019-08-08
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants. Trials, record NCT03888755. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03888755
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Icatibant for Acute Attacks of Hereditary Angioedema in Japanese Participants
- NCT number
- NCT03888755
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 8 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- Icatibant
- First posted
- 2019-03-25
- Last updated
- 2021-06-03
- Results first posted
- 2019-08-08
Source ClinicalTrials.gov
Registered outcomes18
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Onset of Symptom Relief (TOSR) | Baseline up to 120 hours post-treatment | The TOSR was defined as a 50 percent (%) reduction from the pre-treatment score in the 3-symptom composite VAS score for non-laryngeal attacks and 5-symptom composite VAS score for laryngeal attacks. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom. Composite VAS scores were calculated as the average of VAS measurements for skin swelling, skin pain, and abdominal pain (3-symptom composite) for non-laryngeal attacks and for skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change (5-symptom composite) for laryngeal attacks. |
| Secondary | Time to Onset of Primary Symptom Relief (TOSR-P) | Baseline up to 120 hours post-treatment | Primary symptom relief was based on the participant-assessed VAS score for a single primary symptom (determined by edema location) and corresponds to a reduction by 31 mm at a pretreatment VAS of 100 mm and by 21 mm at a pretreatment VAS of 30 mm. If the primary symptom pretreatment VAS less than (\<) 30 mm, then primary symptom relief was defined as 68% reduction from pretreatment. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The TOSR-P was calculated from the time of icatibant administration to the onset of primary symptom relief. |
| Secondary | Change From Baseline in the Composite Visual Analog Scale (VAS) Score | Baseline, 2, 4 and 8 hours post-treatment | A VAS utilizes a scale consisting of a 100 mm horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom. Composite VAS scores was calculated as the average of VAS measurements for skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change (5-symptom composite) for laryngeal attacks and as the average of VAS measurements for skin swelling, skin pain and abdominal pain (3-symptom composite) for non-laryngeal attacks. Change from baseline in the composite VAS score was reported. |
| Secondary | Composite Symptom Score (SS) Assessed by Investigator | 8 hours post dose | The investigator-assessed composite symptom score was calculated as an average of abdominal tenderness, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, and skin swelling (8 symptoms) for non-laryngeal attacks and the average of abdominal tenderness, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, skin swelling, dysphagia, voice change, breathing difficulties, stridor, and asphyxia (13 symptoms) for laryngeal attacks using the following 5-point scale 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities). Here the composite SS assessed by investigator was reported. |
| Secondary | Composite Symptom Score (SS) Assessed by Participant | 8 hours post dose | The participant-assessed composite symptom score was calculated as an average of abdominal pain, nausea, vomiting, diarrhea, skin pain, erythema, skin irritation, and skin swelling (8 symptoms) for non-laryngeal attacks and the average of abdominal pain, nausea, vomiting, diarrhea, skin pain, erythema,skin irritation, skin swelling, dysphagia and voice change (10 symptoms) for laryngeal attacks using the following 5-point scale 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities). Here the composite SS assessed by participant was reported. |
| Secondary | Investigator Global Assessment | 2, 4 and 8 hours post dose | The investigator was made a global assessment (that is \[i.e.\] consideration of all abdominal symptoms combined, all cutaneous symptoms combined and/or all laryngeal symptoms combined) using the following 5-point scale, where the symptoms were scored from 0 for "absence of symptoms" to 4 for "very severe": 0 = none (absence of symptoms); 1 = mild (no to mild interference with daily activities); 2 = moderate (moderate interference with daily activities); 3 = severe (severe interference with daily activities); 4 = very severe (very severe interference with daily activities). |
| Secondary | Time to Initial Symptom Improvement by Investigator | Baseline up to 120 hours post-treatment | Time to initial symptom improvement was evaluated by the investigator; each were asked to record the time at which they perceived initial improvement of symptoms. Time to initial symptom improvement was calculated from the time of icatibant administration to the time reported by the investigator of initial improvement of symptoms. |
| Secondary | Time to Initial Symptom Improvement by Participants | Baseline up to 120 hours post-treatment | Time to initial symptom improvement was evaluated by the participants; each were asked to record the time at which they perceived initial improvement of symptoms. Time to initial symptom improvement was calculated from the time of icatibant administration to the time reported by the participant of initial improvement of symptoms. |
| Secondary | Time to Almost Complete Symptom Relief As Assessed by Visual Analog Scale (VAS) Score | Baseline up to 120 hours post-treatment | Time to almost complete symptom relief was calculated from the time of icatibant administration to almost complete symptom relief. Almost complete symptom relief was determined retrospectively as the earliest of three consecutive non-missing measurements for which all VAS scores \< 10 mm. A VAS utilizes a scale consisting of a 100 millimeter (mm) horizontal line with extreme values at the beginning (0 mm = no symptom) and end (100 mm = worst possible symptom) of the line. The participant should draw a vertical line at the point along the scale that represents the current status of the measured symptom. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of Icatibant After a Single Subcutaneous (SC) Administration of Icatibant | Baseline, 0.75, 2 hours post-treatment | The Cmax was estimated by a population PK modeling approach. The Cmax of icatibant was reported. |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 registered outcomesOutcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Onset of Symptom Relief (TOSR) | Baseline up to 120 hours post-treatment | The treated population included all participants treated with icatibant | Hours | MEDIAN |
| SECONDARY | Time to Onset of Primary Symptom Relief (TOSR-P) | Baseline up to 120 hours post-treatment | The treated population included all participants treated with icatibant | Hours | MEDIAN |
| SECONDARY | Change From Baseline in the Composite Visual Analog Scale (VAS) Score | Baseline, 2, 4 and 8 hours post-treatment | The treated population included all participants treated with icatibant | Score on a scale | MEAN |
| SECONDARY | Composite Symptom Score (SS) Assessed by Investigator | 8 hours post dose | The treated population included all participants treated with icatibant | Score on a scale | MEAN |
| SECONDARY | Composite Symptom Score (SS) Assessed by Participant | 8 hours post dose | The treated population included all participants treated with icatibant | Score on a scale | MEAN |
| SECONDARY | Investigator Global Assessment | 2, 4 and 8 hours post dose | The treated population included all participants who received one dose of icatibant. | Score on a scale | MEAN |
| SECONDARY | Time to Initial Symptom Improvement by Investigator | Baseline up to 120 hours post-treatment | The treated population included all participants treated with icatibant | H | MEDIAN |
| SECONDARY | Time to Initial Symptom Improvement by Participants | Baseline up to 120 hours post-treatment | The treated population included all participants treated with icatibant. | h | MEDIAN |
| SECONDARY | Time to Almost Complete Symptom Relief As Assessed by Visual Analog Scale (VAS) Score | Baseline up to 120 hours post-treatment | The treated population included all participants treated with icatibant | H | MEDIAN |
| SECONDARY | Maximum Observed Plasma Concentration (Cmax) of Icatibant After a Single Subcutaneous (SC) Administration of Icatibant | Baseline, 0.75, 2 hours post-treatment | The pharmacokinetic (PK) analysis population included all participants who received study drug and provided evaluable plasma drug concentrations. | Nano grams per milliliter (ng/mL) | MEAN |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 outcomesResults by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Onset of Symptom Relief (TOSR) | Icatibant | 1.75 | 95% Confidence Interval 1.00 to 2.50 | Hours | |
| Time to Onset of Primary Symptom Relief (TOSR-P) | Icatibant | 1.07 | 95% Confidence Interval 1.00 to 2.00 | Hours | |
| Change From Baseline in the Composite Visual Analog Scale (VAS) Score | Icatibant | Baseline | 30.78 | Standard Deviation 13.465 | Score on a scale |
| Change From Baseline in the Composite Visual Analog Scale (VAS) Score | Icatibant | 2 hours | -19.26 | Standard Deviation 13.310 | Score on a scale |
| Change From Baseline in the Composite Visual Analog Scale (VAS) Score | Icatibant | 4 hours | -24.57 | Standard Deviation 13.367 | Score on a scale |
| Change From Baseline in the Composite Visual Analog Scale (VAS) Score | Icatibant | 8 hours | -29.40 | Standard Deviation 12.998 | Score on a scale |
| Composite Symptom Score (SS) Assessed by Investigator | Icatibant | 0.12 | Standard Deviation 0.18 | Score on a scale | |
| Composite Symptom Score (SS) Assessed by Participant | Icatibant | 0.14 | Standard Deviation 0.16 | Score on a scale | |
| Investigator Global Assessment | Icatibant | Cutaneous Symptoms: 2 hours (h) post dose | 0.9 | Standard Deviation 0.99 | Score on a scale |
| Investigator Global Assessment | Icatibant | Cutaneous Symptoms: 4 h post dose | 0.6 | Standard Deviation 0.52 | Score on a scale |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Icatibant | 8 | |
| Overall Study | COMPLETED | Icatibant | 8 | |
| Overall Study | NOT COMPLETED | Icatibant | 0 |
Source ClinicalTrials.gov
Adverse events2
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 | HEREDITARY ANGIOEDEMA | Congenital, familial and genetic disorders | Icatibant | 2 | 8 | 2 |
| other | HEADACHE | Nervous system disorders | Icatibant | 1 | 8 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Icatibant | 0 | 8 |
| Total, other adverse events | Icatibant | 3 | 8 |
| Total, serious adverse events | Icatibant | 0 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
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