Trial · NCT00292981
C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
NCT00292981, Phase 3, Completed, CSL Behring; results first posted 2011-06-23
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study). Trials, record NCT00292981. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00292981
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)
- NCT number
- NCT00292981
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 57 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Hereditary Angioedema
- Interventions
- C1 Esterase Inhibitor
- First posted
- 2006-02-16
- Last updated
- 2015-05-07
- Results first posted
- 2011-06-23
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population) | Up to 24 h after start of study treatment | The start of symptom relief was determined by subject self-assessment. |
| Primary | Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population) | Up to 24 h after start of study treatment | The start of symptom relief was determined by subject self-assessment. |
| Secondary | Time to Complete Resolution of All HAE Symptoms (ITT Subject Population) | Up to Day 9 following an attack | Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card. |
| Secondary | Time to Complete Resolution of All HAE Symptoms (ITT Attack Population) | Up to Day 9 following an attack | Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population) | Up to 24 h after start of study treatment | Intent to treat (ITT) subject population: All subjects admitted to the study who received any portion of the study medication. | hours | MEDIAN |
| SECONDARY | Time to Complete Resolution of All HAE Symptoms (ITT Subject Population) | Up to Day 9 following an attack | Intent to treat (ITT) subject population: All subjects admitted to the study who received any portion of the study medication. | hours | MEDIAN |
| PRIMARY | Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population) | Up to 24 h after start of study treatment | ITT attack population: All attacks in subjects admitted to the study for which any portion of study medication was administered. | hours | MEDIAN |
| SECONDARY | Time to Complete Resolution of All HAE Symptoms (ITT Attack Population) | Up to Day 9 following an attack | ITT attack population: All attacks in subjects admitted to the study for which any portion of study medication was administered. | 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 Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population) | C1 Esterase Inhibitor | 0.46 | 95% Confidence Interval 0.39 to 0.53 | hours | |
| Time to Complete Resolution of All HAE Symptoms (ITT Subject Population) | C1 Esterase Inhibitor | 15.48 | 95% Confidence Interval 11.64 to 21.59 | hours | |
| Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population) | C1 Esterase Inhibitor | 0.37 | 95% Confidence Interval 0.33 to 0.42 | hours | |
| Time to Complete Resolution of All HAE Symptoms (ITT Attack Population) | C1 Esterase Inhibitor | 14.28 | 95% Confidence Interval 12.07 to 15.80 | hours |
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 | C1 Esterase Inhibitor | 57 | |
| Overall Study | COMPLETED | C1 Esterase Inhibitor | 18 | |
| Overall Study | NOT COMPLETED | C1 Esterase Inhibitor | 39 |
Source ClinicalTrials.gov
Adverse events46
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 | C1 Esterase Inhibitor | 1 | 57 | |
| other | Conjunctivitis | Eye disorders | C1 Esterase Inhibitor | 1 | 57 | |
| other | Abdominal discomfort | Gastrointestinal disorders | C1 Esterase Inhibitor | 2 | 57 | |
| other | Abdominal pain | Gastrointestinal disorders | C1 Esterase Inhibitor | 2 | 57 | |
| other | Abdominal distension | Gastrointestinal disorders | C1 Esterase Inhibitor | 1 | 57 | |
| other | Abdominal tenderness | Gastrointestinal disorders | C1 Esterase Inhibitor | 1 | 57 | |
| other | Constipation | Gastrointestinal disorders | C1 Esterase Inhibitor | 1 | 57 | |
| other | Dry mouth | Gastrointestinal disorders | C1 Esterase Inhibitor | 1 | 57 | |
| other | Nausea | Gastrointestinal disorders | C1 Esterase Inhibitor | 1 | 57 | |
| other | Influenza like illness | General disorders | C1 Esterase Inhibitor | 2 | 57 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | C1 Esterase Inhibitor | ||
| Total, other adverse events | C1 Esterase Inhibitor | 25 | 57 |
| Total, serious adverse events | C1 Esterase Inhibitor | 1 | 57 |
Source ClinicalTrials.gov
Papers7
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.
Source
- Release
- trials-2026-11-12-0.4.0
- Release manifest SHA-256
- 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4
- Registry capture
- 2026-11-12
- Results copy, AACT
- 2026-03-23
- NIH clinical studies file
- 2026-11-13
Source ClinicalTrials.gov
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNone 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/NCT00292981
GET https://conductscience.org/api/trials/v1/NCT00292981/events?page=2