Trial · NCT01457430
Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE
NCT01457430, Phase 4, Completed, Massachusetts General Hospital; results first posted 2016-10-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE. Trials, record NCT01457430. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01457430
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Tolerability of Icatibant for the Treatment of HAE
- NCT number
- NCT01457430
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 19 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Hereditary Angioedema
- Interventions
- Icatibant
- First posted
- 2011-10-24
- Last updated
- 2016-10-18
- Results first posted
- 2016-10-18
- Limitations and caveats
- All adverse events were recorded and assessed out of total attacks, not total participants. There were 78 HAE attacks; 4 adverse events were identified.
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 Complete or Near Complete Resolution From Onset of Symptoms | Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours | Time of onset of HAE attack, time icatibant was administered, and time to complete relief of symptoms were recorded in minutes. Time to complete relief of symptoms was defined as time from onset of symptoms to complete or near complete resolution as reported by the patient. |
| Secondary | Percent Change in VAS Scores | Percent Change in VAS Score from Baseline to 4 Hours | Baseline, 4 hours VAS scale ranges from 0-100 with 0 being the lowest severity and 100 being the highest severity |
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 Complete or Near Complete Resolution From Onset of Symptoms | Time to complete or near complete resolution of symptoms as reported by the patient, an expected average of 8-10 hours | minutes | MEDIAN | |
| SECONDARY | Percent Change in VAS Scores | Percent Change in VAS Score from Baseline to 4 Hours | percent change | 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 Complete or Near Complete Resolution From Onset of Symptoms | Icatibant Treatment With Health Care Provider | 735 | Inter-Quartile Range 339 to 1563 | minutes | |
| Time to Complete or Near Complete Resolution From Onset of Symptoms | Icatibant Treatment by Self Administration | 377 | Inter-Quartile Range 220 to 618 | minutes | |
| Percent Change in VAS Scores | Icatibant Treatment With Health Care Provider | -97 | Inter-Quartile Range -100 to -73 | percent change | |
| Percent Change in VAS Scores | Icatibant Treatment by Self Administration | -96 | Inter-Quartile Range -100 to -80 | percent change |
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 | 19 | |
| Overall Study | COMPLETED | Icatibant | 19 | |
| Overall Study | NOT COMPLETED | Icatibant | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Fatigue | Blood and lymphatic system disorders | Icatibant | 1 | 78 | 1 |
| other | Fever | Blood and lymphatic system disorders | Icatibant | 1 | 78 | 1 |
| other | Dizziness | Nervous system disorders | Icatibant | 1 | 78 | 1 |
| other | Nausea | Gastrointestinal disorders | Icatibant | 1 | 78 | 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 | ||
| Total, other adverse events | Icatibant | 4 | 78 |
| Total, serious adverse events | Icatibant | 0 | 78 |
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.
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/NCT01457430
GET https://conductscience.org/api/trials/v1/NCT01457430/registered