Trial · NCT00500656
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)
NCT00500656, Phase 3, Completed, Shire; results first posted 2014-06-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE). Trials, record NCT00500656. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00500656
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)
- NCT number
- NCT00500656
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 85 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema
- Interventions
- Icatibant, Tranexamic Acid, Oral Placebo, S.C. Placebo
- First posted
- 2007-07-13
- Last updated
- 2021-06-09
- Other registries' IDs
- eudract:2004-001540-71
- Results first posted
- 2014-06-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Onset of Symptom Relief. | 2 days | The primary efficacy endpoint was Time to onset of symptom relief (TOSR) following treatment with either icatibant or tranexamic acid. The median time to onset of symptom relief for the icatibant group was compared to the the median time to onset of symptom relief for the tranexamic acid group. TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the three primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain. The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe. |
| Secondary | Time to Almost Complete Symptom Relief | 48 hours | Almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least three consecutive measurements for all symptoms. |
Source ClinicalTrials.gov
Outcomes2
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. | 2 days | Hours | MEDIAN | |
| SECONDARY | Time to Almost Complete Symptom Relief | 48 hours | Hours | MEDIAN |
Source ClinicalTrials.gov
Results by group4
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. | Randomized Controlled -Icatibant | 2.0 | Inter-Quartile Range 1.0 to 3.5 | Hours | |
| Time to Onset of Symptom Relief. | Randomized Controlled-Tranexamic Acid | 12.0 | Inter-Quartile Range 3.5 to 25.4 | Hours | |
| Time to Almost Complete Symptom Relief | Randomized Controlled -Icatibant | 10.0 | Inter-Quartile Range 2.8 to 23.2 | Hours | |
| Time to Almost Complete Symptom Relief | Randomized Controlled-Tranexamic Acid | 51.0 | Inter-Quartile Range 12.0 to 79.5 | Hours |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Controlled Phase | STARTED | Randomized Controlled -Icatibant | 36 | |
| Controlled Phase | STARTED | Randomized Controlled-Tranexamic Acid | 38 | |
| Controlled Phase | STARTED | Controlled Open-label / Laryngeal Attack | 3 | |
| Controlled Phase | STARTED | Untreated Patients at the Baseline | 8 | |
| Controlled Phase | COMPLETED | Randomized Controlled -Icatibant | 26 | |
| Controlled Phase | COMPLETED | Randomized Controlled-Tranexamic Acid | 28 | |
| Controlled Phase | COMPLETED | Controlled Open-label / Laryngeal Attack | 2 | |
| Controlled Phase | COMPLETED | Untreated Patients at the Baseline | 0 | |
| Controlled Phase | NOT COMPLETED | Randomized Controlled -Icatibant | 10 | |
| Controlled Phase | NOT COMPLETED | Randomized Controlled-Tranexamic Acid | 10 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events198
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 Subjects ) | 10 | 36 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | Controlled Phase- Tranexamic Acid (Randomized Subjects) | 6 | 38 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack) | 1 | 3 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | Open Label Extension Phase- Icatibant (Previously Randomized) | 10 | 44 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | Open Label Extension Phase (Subjects w/ Laryngeal Attack) | 1 | 2 | |
| other | Hereditary Angioedema | Congenital, familial and genetic disorders | Open Label Extension Phase(Untreated Patients at the Baseline | 1 | 8 | |
| other | Injection Site Reaction | General disorders | Controlled Phase- Icatibant (Randomized Subjects ) | 2 | 36 | |
| other | Injection Site Reaction | General disorders | Controlled Phase- Tranexamic Acid (Randomized Subjects) | 0 | 38 | |
| other | Injection Site Reaction | General disorders | Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack) | 0 | 3 | |
| other | Injection Site Reaction | General disorders | Open Label Extension Phase- Icatibant (Previously Randomized) | 1 | 44 |
1 to 10 of 198Source ClinicalTrials.gov
See all 198 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Controlled Phase- Icatibant (Randomized Subjects ) | ||
| Total, all-cause mortality | Controlled Phase- Tranexamic Acid (Randomized Subjects) | ||
| Total, all-cause mortality | Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack) | ||
| Total, all-cause mortality | Open Label Extension Phase- Icatibant (Previously Randomized) | ||
| Total, all-cause mortality | Open Label Extension Phase (Subjects w/ Laryngeal Attack) | ||
| Total, all-cause mortality | Open Label Extension Phase(Untreated Patients at the Baseline | ||
| Total, other adverse events | Controlled Phase- Icatibant (Randomized Subjects ) | 19 | 36 |
| Total, other adverse events | Controlled Phase- Tranexamic Acid (Randomized Subjects) | 16 | 38 |
| Total, other adverse events | Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack) | 1 | 3 |
| Total, other adverse events | Open Label Extension Phase- Icatibant (Previously Randomized) | 31 | 44 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers3
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
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/NCT00500656
GET https://conductscience.org/api/trials/v1/NCT00500656/flow?page=2