Trial · NCT01188564
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
NCT01188564, Phase 3, Completed, Pharming Technologies B.V.; results first posted 2015-08-07
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks. Trials, record NCT01188564. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01188564
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
- NCT number
- NCT01188564
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- Pharming Technologies B.V.
- Conditions
- Hereditary Angioedema
- Interventions
- rhC1INH, Placebo (Saline)
- First posted
- 2010-08-25
- Last updated
- 2015-08-07
- Results first posted
- 2015-08-07
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 Beginning of Relief of Symptoms | Patients observed for 24 hours | Time to beginning of relief is the time lapsed from the beginning of the infusion of study medication to the beginning of a beneficial effect based on patient's responses to the Treatmetn Effect Questionnaire (TEQ) for the primary attack location. The beginning of relief is defined as the first timepoint at which * The patient reports any of the following answers for TEQ question 1: "A little better", "Better" or "Much better"; and; * The patient reports the following answer for TEQ question 2: "Yes"; and, * There is persistence in improvement at the next assessment time, i.e.either the same or a better response to Question 1 and "Yes" to Question 2. |
| Secondary | Time to Minimal Symptoms | 24 hours | The key secondary efficacy endpoint was the time to minimal symptoms at all locations. The time to achieving minimal symptoms was defined as an answer of "Yes" to TEQ question 3. |
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 Beginning of Relief of Symptoms | Patients observed for 24 hours | minutes | MEDIAN | |
| SECONDARY | Time to Minimal Symptoms | 24 hours | minutes | 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 Beginning of Relief of Symptoms | rhC1INH | 90 | 95% Confidence Interval 61 to 150 | minutes | |
| Time to Beginning of Relief of Symptoms | Placebo (Saline) | 152 | 95% Confidence Interval 93 to NA | minutes | |
| Time to Minimal Symptoms | rhC1INH | 303 | Full Range 240 to 720 | minutes | |
| Time to Minimal Symptoms | Placebo (Saline) | 483 | Full Range 300 to 1440 | minutes |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Phase | STARTED | rhC1INH | 44 | |
| Double-blind Phase | STARTED | Placebo (Saline) | 31 | |
| Double-blind Phase | COMPLETED | rhC1INH | 43 | |
| Double-blind Phase | COMPLETED | Placebo (Saline) | 31 | |
| Double-blind Phase | NOT COMPLETED | rhC1INH | 1 | |
| Double-blind Phase | NOT COMPLETED | Placebo (Saline) | 0 | |
| Open Label Phase | STARTED | rhC1INH | 24 | |
| Open Label Phase | STARTED | Placebo (Saline) | 20 | |
| Open Label Phase | COMPLETED | rhC1INH | 24 | |
| Open Label Phase | COMPLETED | Placebo (Saline) | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events22
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 | Sinus congestion | Respiratory, thoracic and mediastinal disorders | rhC1INH | 0 | 56 | 0 |
| other | Sinus congestion | Respiratory, thoracic and mediastinal disorders | Placebo (Saline) | 1 | 18 | 1 |
| other | Sneezing | Respiratory, thoracic and mediastinal disorders | rhC1INH | 1 | 56 | 1 |
| other | Sneezing | Respiratory, thoracic and mediastinal disorders | Placebo (Saline) | 0 | 18 | 0 |
| other | Vasomotor rhinitis | Respiratory, thoracic and mediastinal disorders | rhC1INH | 0 | 56 | 0 |
| other | Vasomotor rhinitis | Respiratory, thoracic and mediastinal disorders | Placebo (Saline) | 1 | 18 | 1 |
| other | Diarrhea | Gastrointestinal disorders | rhC1INH | 0 | 56 | 0 |
| other | Diarrhea | Gastrointestinal disorders | Placebo (Saline) | 1 | 18 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | rhC1INH | 0 | 56 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Placebo (Saline) | 1 | 18 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rhC1INH | ||
| Total, all-cause mortality | Placebo (Saline) | ||
| Total, other adverse events | rhC1INH | 6 | 56 |
| Total, other adverse events | Placebo (Saline) | 4 | 18 |
| Total, serious adverse events | rhC1INH | 1 | 56 |
| Total, serious adverse events | Placebo (Saline) | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42159953 | DERIVED |
Source PubMed
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| rhC1INH vs Placebo (Saline): serious adverse events |
Source 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/NCT01188564
GET https://conductscience.org/api/trials/v1/NCT01188564/events?page=2