Trial · NCT00289211
C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
NCT00289211, Phase 3, Completed, Shire; results first posted 2010-06-02
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks. Trials, record NCT00289211. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00289211
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
- NCT number
- NCT00289211
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 83 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema
- Interventions
- C1 esterase inhibitor [human] (C1INH-nf), Placebo (saline)
- First posted
- 2006-02-09
- Last updated
- 2021-06-11
- Results first posted
- 2010-06-02
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Beginning of Substantial Relief of the Defining Symptom | Within 4 hours after initial treatment | Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments. |
| Secondary | Number of Subjects With Beginning of Substantial Relief of the Defining Symptom | Within 4 hours after initial treatment | Randomized subjects assessed their symptoms every 15 minutes up to 4 hours after the initial dose of blinded study drug or until substantial relief of the defining symptom was achieved. Substantial relief was defined as 3 consecutive assessments of improvement of the defining symptom. Beginning of substantial relief was considered the first of the 3 consecutive assessments. |
| Secondary | Time to Complete Resolution of the HAE Attack | 72 hours | Randomized subjects were contacted 72-96 hours (3-4 days) after discharge from the study site to determine when complete resolution of the HAE attack occurred. |
| Secondary | Antigenic C1 Inhibitor (C1INH) Serum Levels | Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion | Change in antigenic C1INH serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug. |
| Secondary | Functional C1INH Serum Levels | Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion | Percent change in functional C1INH serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug. Functional C1INH serum levels are expressed as a percent of total detectable C1INH (ie, functional C1INH/total detectable C1INH). |
| Secondary | Complement C4 Serum Levels | Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion | Change in complement C4 serum levels from pre-infusion to 1-, 2-, 4-, and 12 hours after the initial dose of blinded study drug. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Beginning of Substantial Relief of the Defining Symptom | Within 4 hours after initial treatment | Intent-to-treat (ITT) Population (all randomized subjects). Since less than 50% of subjects in the placebo group achieved the endpoint, median time to event was not estimable (NE). Further, the number of censored events in the C1INH-nf and placebo groups precluded estimation of the 95% confidence interval (CI) upper bound for median time to event. | hours | MEDIAN |
| SECONDARY | Number of Subjects With Beginning of Substantial Relief of the Defining Symptom | Within 4 hours after initial treatment | ITT-Efficacy (ITT-E) Population (N=68; 3 of the 71 randomized \[ie, ITT\] subjects were excluded from the ITT-E Population, as it was later determined that they did not experience a definitive hereditary angioedema \[HAE\] attack). | participants | NUMBER |
| SECONDARY | Time to Complete Resolution of the HAE Attack | 72 hours | ITT Population. | hours | MEDIAN |
| SECONDARY | Antigenic C1 Inhibitor (C1INH) Serum Levels | Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion | ITT-E subjects (N=68) with data available. | mg/dL | MEAN |
| SECONDARY | Functional C1INH Serum Levels | Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion | ITT-E subjects (N=68) with data available. | percent of functional C1INH | MEAN |
| SECONDARY | Complement C4 Serum Levels | Pre-infusion to 1-, 2-, 4-, and 12 hours post-infusion | ITT-E subjects (N=68) with data available. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Beginning of Substantial Relief of the Defining Symptom | C1INH-nf | 2.0 | 95% Confidence Interval 1.0 to 4.0 | hours | |
| Time to Beginning of Substantial Relief of the Defining Symptom | Placebo | 4.0 | 95% Confidence Interval 2.0 to 4.0 | hours | |
| Number of Subjects With Beginning of Substantial Relief of the Defining Symptom | C1INH-nf | 21 | participants | ||
| Number of Subjects With Beginning of Substantial Relief of the Defining Symptom | Placebo | 14 | participants | ||
| Time to Complete Resolution of the HAE Attack | C1INH-nf | 12.3 | 95% Confidence Interval 10.1 to 18.0 | hours | |
| Time to Complete Resolution of the HAE Attack | Placebo | 31.6 | 95% Confidence Interval 17.8 to 46.0 | hours | |
| Antigenic C1 Inhibitor (C1INH) Serum Levels | C1INH-nf | Pre-infusion (N=34, N=33) | 14.7 | Standard Deviation 22.21 | mg/dL |
| Antigenic C1 Inhibitor (C1INH) Serum Levels | Placebo | Pre-infusion (N=34, N=33) | 13.0 | Standard Deviation 16.42 | mg/dL |
| Antigenic C1 Inhibitor (C1INH) Serum Levels | C1INH-nf | Change at 1 hour post-infusion (N=35, N=32) | 6.7 | Standard Deviation 8.86 | mg/dL |
| Antigenic C1 Inhibitor (C1INH) Serum Levels | Placebo | Change at 1 hour post-infusion (N=35, N=32) | -0.9 | Standard Deviation 9.25 | mg/dL |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | C1INH-nf | 36 | |
| Overall Study | STARTED | Placebo | 35 | |
| Overall Study | STARTED | Open-label C1INH-nf Only | 12 | |
| Overall Study | COMPLETED | C1INH-nf | 36 | |
| Overall Study | COMPLETED | Placebo | 34 | |
| Overall Study | COMPLETED | Open-label C1INH-nf Only | 2 | |
| Overall Study | NOT COMPLETED | C1INH-nf | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 1 | |
| Overall Study | NOT COMPLETED | Open-label C1INH-nf Only | 10 |
Source ClinicalTrials.gov
Adverse events6
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 | Dermatitis contact | Skin and subcutaneous tissue disorders | C1INH-nf | 1 | 71 | |
| other | Dermatitis contact | Skin and subcutaneous tissue disorders | Placebo | 0 | 12 | |
| other | Injection site rash | General disorders | C1INH-nf | 1 | 71 | |
| other | Injection site rash | General disorders | Placebo | 0 | 12 | |
| other | Tetany | Metabolism and nutrition disorders | C1INH-nf | 0 | 71 | |
| other | Tetany | Metabolism and nutrition disorders | Placebo | 1 | 12 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | C1INH-nf | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | C1INH-nf | 2 | 71 |
| Total, other adverse events | Placebo | 1 | 12 |
| Total, serious adverse events | C1INH-nf | 0 | 71 |
| Total, serious adverse events | Placebo | 0 | 12 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| C1INH-nf vs Placebo: Number of Subjects With Beginning of Substantial Relief of the Defining Symptom | Trial comparisons |
| C1INH-nf vs Placebo: serious adverse events | Trial comparisons |
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/NCT00289211
GET https://conductscience.org/api/trials/v1/NCT00289211/results?page=2