Trial · NCT00097695
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema
NCT00097695, Phase 3, Completed, Shire; results first posted 2013-12-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema. Trials, record NCT00097695. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00097695
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
- NCT number
- NCT00097695
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 84 participants, actual
- Lead sponsor
- Shire
- Conditions
- Angioedema
- Interventions
- Icatibant, Placebo
- First posted
- 2004-11-29
- Last updated
- 2021-06-09
- Results first posted
- 2013-12-24
Source ClinicalTrials.gov
Registered outcomes3
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) | 5 days | The primary efficacy endpoint was TOSR assessed by the patient using a Visual Analogue Scale (VAS). The VAS is a scale used to measure intensity of each symptom of the attack at baseline and at the pre-determined time points throughout treatment period. It consists of a horizontal 10cm line, with the 0 point corresponding to a state where patient experiences no symptoms at all and the 10cm point represents the worst symptoms ever experienced by patient. The patient indicates his/her current state of symptoms by drawing a mark across the horizontal line. TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the 3 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 Regression (Start of Improvement) According to Patient | 5 days | This parameter assessed the time to regression (start of improvement) of observable(visible) symptoms according to the patients. Patients were asked "Report date and time when you feel that your symptoms start to improve". |
| Secondary | Time to Almost Complete Symptom Relief | 5 days | The time to almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least 3 consecutive measurements for all symptom. |
Source ClinicalTrials.gov
Outcomes3
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) | 5 days | Time to onset of symptom relief - Controlled phase - ITT population (patients experiencing moderate to very severe acute cutaneous and/or abdominal HAE attacks) | Hours | MEDIAN |
| SECONDARY | Time to Regression (Start of Improvement) According to Patient | 5 days | Hours | MEDIAN | |
| SECONDARY | Time to Almost Complete Symptom Relief | 5 days | Hours | 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 |
|---|---|---|---|---|---|
| Time to Onset of Symptom Relief (TOSR) | Randomized -Icatibant | 2.5 | Inter-Quartile Range 1.1 to 6.0 | Hours | |
| Time to Onset of Symptom Relief (TOSR) | Randomized -Placebo | 4.6 | Inter-Quartile Range 1.8 to 10.2 | Hours | |
| Time to Regression (Start of Improvement) According to Patient | Randomized -Icatibant | 0.8 | Inter-Quartile Range 0.5 to 2.0 | Hours | |
| Time to Regression (Start of Improvement) According to Patient | Randomized -Placebo | 16.9 | Inter-Quartile Range 3.2 to NA | Hours | |
| Time to Almost Complete Symptom Relief | Randomized Control Trial-icatibant | 8.5 | Inter-Quartile Range 2.5 to 31.5 | Hours | |
| Time to Almost Complete Symptom Relief | Randomized Control Trial-placebo | 19.4 | Inter-Quartile Range 10.2 to 55.7 | Hours |
Source ClinicalTrials.gov
Participant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| The Controlled Phase | STARTED | Randomized -Icatibant | 27 | |
| The Controlled Phase | STARTED | Randomized -Placebo | 29 | |
| The Controlled Phase | STARTED | Controlled Open-label / Laryngeal Attack | 8 | |
| The Controlled Phase | STARTED | Untreated Patients at the Baseline | 20 | |
| The Controlled Phase | COMPLETED | Randomized -Icatibant | 23 | |
| The Controlled Phase | COMPLETED | Randomized -Placebo | 26 | |
| The Controlled Phase | COMPLETED | Controlled Open-label / Laryngeal Attack | 3 | |
| The Controlled Phase | COMPLETED | Untreated Patients at the Baseline | 0 | |
| The Controlled Phase | NOT COMPLETED | Randomized -Icatibant | 4 | |
| The Controlled Phase | NOT COMPLETED | Randomized -Placebo | 3 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events78
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 | Dizziness | Investigations | Controlled Phase- Icatibant (Randomized Subjects ) | 2 | 27 | |
| other | Dizziness | Investigations | Controlled Phase- Placebo (Randomized Subjects | 1 | 29 | |
| other | Dizziness | Investigations | Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack) | 0 | 8 | |
| other | Dizziness | Investigations | Open Label Extension Phase- Icatibant (Previously Randomized) | 0 | 49 | |
| other | Dizziness | Investigations | Open Label Extension -Icatibant (Subjects w/ Laryngeal Attack) | 1 | 3 | |
| other | Dizziness | Investigations | Open Label Extension Phase(Untreated Patients at the Baseline) | 0 | 20 | |
| other | Headache/Migraine | Nervous system disorders | Controlled Phase- Icatibant (Randomized Subjects ) | 0 | 27 | |
| other | Headache/Migraine | Nervous system disorders | Controlled Phase- Placebo (Randomized Subjects | 2 | 29 | |
| other | Headache/Migraine | Nervous system disorders | Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack) | 2 | 8 | |
| other | Headache/Migraine | Nervous system disorders | Open Label Extension Phase- Icatibant (Previously Randomized) | 0 | 49 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 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- Placebo (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 -Icatibant (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 ) | 12 | 27 |
| Total, other adverse events | Controlled Phase- Placebo (Randomized Subjects | 19 | 29 |
| Total, other adverse events | Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack) | 6 | 8 |
| Total, other adverse events | Open Label Extension Phase- Icatibant (Previously Randomized) | 39 | 49 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers2
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/NCT00097695
GET https://conductscience.org/api/trials/v1/NCT00097695/flow?page=2