Trial · NCT00912093
A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
NCT00912093, Phase 3, Completed, Shire; results first posted 2014-08-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3). Trials, record NCT00912093. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00912093
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Icatibant in Patients With Acute Attacks of Hereditary Angioedema (FAST-3)
- NCT number
- NCT00912093
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 98 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema
- Interventions
- Icatibant, Placebo
- First posted
- 2009-06-03
- Last updated
- 2021-06-11
- Other registries' IDs
- eudract:2009-015606-19
- Results first posted
- 2014-08-06
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient | Up to 120 hours post-dose | Time to onset of symptom relief was calculated from study drug administration to onset of symptom relief, where onset of symptom relief was defined as the earliest of 3 consecutive measurements in which there was a 50% reduction from pretreatment in composite VAS score. Composite VAS score comprised 3 symptoms, including skin swelling, skin pain, and abdominal pain, for cutaneous and abdominal attacks and 5 symptoms, including skin swelling, skin pain, abdominal pain, difficulty swallowing, and voice change, for laryngeal attacks. Subjects who did not achieve symptom relief within the observation period were censored at the last observation time. |
| Secondary | Time to Onset of Primary Symptom Relief | Up to 120 hours post-dose | Time to primary symptom relief was calculated from the time of study drug administration to the onset of primary symptom relief, where onset of primary symptom relief was determined using the subject-assessed VAS score for a single primary symptom (determined by edema location) and defined as the earliest of 3 consecutive non-missing measurements in which a pre-specified reduction from the pretreatment value was met. Subjects who did not achieve primary symptom relief within the observation period were censored at the last observation time. |
| Secondary | Time to Almost Complete Symptom Relief | Up to 120 Hours post treatment | Time to almost complete symptom relief was calculated from the time of study drug administration to almost complete symptom relief, where almost complete symptom relief was defined as the earliest of 3 consecutive non-missing measurements in which all VAS scores \<10 mm. Subjects who did not achieve almost complete symptom relief within the observation period were censored at the last observation time. |
| Secondary | Time to Subject-Assessed Initial Symptom Improvement | Up to 120 hours post-dose | Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the subject as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time. |
| Secondary | Time to Investigator-Assessed Initial Symptom Improvement | Up to 120 hours post-dose | Time to initial symptom improvement was calculated from the time of study drug administration to initial symptom improvement as determined by the investigator as the time they felt symptoms were starting to improve. Subjects who did not achieve initial symptom improvement within the observation period were censored at the last observation time. |
Source ClinicalTrials.gov
Outcomes5
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 for an Acute Attack, as Assessed by the Patient | Up to 120 hours post-dose | Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy. | Hours | MEDIAN |
| SECONDARY | Time to Onset of Primary Symptom Relief | Up to 120 hours post-dose | Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy. | Hours | MEDIAN |
| SECONDARY | Time to Almost Complete Symptom Relief | Up to 120 Hours post treatment | Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy. | Hours | MEDIAN |
| SECONDARY | Time to Subject-Assessed Initial Symptom Improvement | Up to 120 hours post-dose | Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy. | Hours | MEDIAN |
| SECONDARY | Time to Investigator-Assessed Initial Symptom Improvement | Up to 120 hours post-dose | Non-laryngeal Intent-to-Treat (nl-ITT) population included all subjects with non-laryngeal attacks of HAE randomized to treatment. Subjects were analyzed according to the randomized treatment regardless of the treatment actually received. This was the primary analysis population for efficacy. | Hours | MEDIAN |
Source ClinicalTrials.gov
Results by group10
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 for an Acute Attack, as Assessed by the Patient | Randomized-Icatibant (Blinded Treatment)--Non-laryngeal | 2.0 | 95% Confidence Interval 1.5 to 3.0 | Hours | |
| Time to Onset of Symptom Relief for an Acute Attack, as Assessed by the Patient | Randomized-Placebo (Blinded Treatment)-Non-laryngeal | 19.8 | 95% Confidence Interval 6.1 to 26.3 | Hours | |
| Time to Onset of Primary Symptom Relief | Randomized-Icatibant (Blinded Treatment)--Non-laryngeal | 1.5 | 95% Confidence Interval 1.0 to 2.0 | Hours | |
| Time to Onset of Primary Symptom Relief | Randomized-Placebo (Blinded Treatment)-Non-laryngeal | 18.5 | 95% Confidence Interval 3.6 to 23.9 | Hours | |
| Time to Almost Complete Symptom Relief | Randomized-Icatibant (Blinded Treatment)--Non-laryngeal | 8.0 | 95% Confidence Interval 5.0 to 42.5 | Hours | |
| Time to Almost Complete Symptom Relief | Randomized-Placebo (Blinded Treatment)-Non-laryngeal | 36.0 | 95% Confidence Interval 29.0 to 50.9 | Hours | |
| Time to Subject-Assessed Initial Symptom Improvement | Randomized-Icatibant (Blinded Treatment)--Non-laryngeal | 0.8 | 95% Confidence Interval 0.5 to 1.0 | Hours | |
| Time to Subject-Assessed Initial Symptom Improvement | Randomized-Placebo (Blinded Treatment)-Non-laryngeal | 3.5 | 95% Confidence Interval 1.9 to 5.4 | Hours | |
| Time to Investigator-Assessed Initial Symptom Improvement | Randomized-Icatibant (Blinded Treatment)--Non-laryngeal | 0.8 | 95% Confidence Interval 0.6 to 1.3 | Hours | |
| Time to Investigator-Assessed Initial Symptom Improvement | Randomized-Placebo (Blinded Treatment)-Non-laryngeal | 3.4 | 95% Confidence Interval 2.6 to 6.0 | Hours |
Source ClinicalTrials.gov
Participant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| The Controlled Phase | STARTED | Randomized-Icatibant (Blinded Treatment)-Non-laryngeal | 43 | |
| The Controlled Phase | STARTED | Randomized-Placebo (Blinded Treatment)-Non-laryngeal | 45 | |
| The Controlled Phase | STARTED | Randomized-Icatibant (Blinded Treatment)-Laryngeal | 3 | |
| The Controlled Phase | STARTED | Randomized-Placebo (Blinded Treatment)-Laryngeal | 2 | |
| The Controlled Phase | STARTED | Open-Label Icatibant-Severe Laryngeal | 5 | |
| The Controlled Phase | COMPLETED | Randomized-Icatibant (Blinded Treatment)-Non-laryngeal | 43 | |
| The Controlled Phase | COMPLETED | Randomized-Placebo (Blinded Treatment)-Non-laryngeal | 43 | |
| The Controlled Phase | COMPLETED | Randomized-Icatibant (Blinded Treatment)-Laryngeal | 3 | |
| The Controlled Phase | COMPLETED | Randomized-Placebo (Blinded Treatment)-Laryngeal | 2 | |
| The Controlled Phase | COMPLETED | Open-Label Icatibant-Severe Laryngeal | 4 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events48
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 | Controlled Phase - Icatibant (Randomized) | 5 | 46 | 5 |
| other | Hereditary angioedema | Congenital, familial and genetic disorders | Controlled Phase -Placebo (Randomized) | 9 | 46 | 9 |
| other | Hereditary angioedema | Congenital, familial and genetic disorders | Controlled Phase - Icatibant (Open Label) | 0 | 6 | 0 |
| other | Hereditary angioedema | Congenital, familial and genetic disorders | Open Label Extension - Icatibant (Open Label) | 11 | 82 | 17 |
| other | Headache | Nervous system disorders | Controlled Phase - Icatibant (Randomized) | 3 | 46 | 4 |
| other | Headache | Nervous system disorders | Controlled Phase -Placebo (Randomized) | 3 | 46 | 3 |
| other | Headache | Nervous system disorders | Controlled Phase - Icatibant (Open Label) | 0 | 6 | 0 |
| other | Headache | Nervous system disorders | Open Label Extension - Icatibant (Open Label) | 9 | 82 | 12 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Controlled Phase - Icatibant (Randomized) | 0 | 46 | 0 |
| other | Upper Respiratory Tract Infection | Infections and infestations | Controlled Phase -Placebo (Randomized) | 0 | 46 | 0 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Controlled Phase - Icatibant (Randomized) | ||
| Total, all-cause mortality | Controlled Phase -Placebo (Randomized) | ||
| Total, all-cause mortality | Controlled Phase - Icatibant (Open Label) | ||
| Total, all-cause mortality | Open Label Extension - Icatibant (Open Label) | ||
| Total, other adverse events | Controlled Phase - Icatibant (Randomized) | 8 | 46 |
| Total, other adverse events | Controlled Phase -Placebo (Randomized) | 12 | 46 |
| Total, other adverse events | Controlled Phase - Icatibant (Open Label) | 0 | 6 |
| Total, other adverse events | Open Label Extension - Icatibant (Open Label) | 23 | 82 |
| Total, serious adverse events | Controlled Phase - Icatibant (Randomized) | 0 | 46 |
| Total, serious adverse events | Controlled Phase -Placebo (Randomized) | 5 | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers4
The papers the trial lists on ClinicalTrials.gov.
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
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The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00912093
GET https://conductscience.org/api/trials/v1/NCT00912093/flow?page=2