Trial · NCT00262301
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
NCT00262301, Phase 3, Completed, Pharming Technologies B.V.; results first posted 2012-08-30
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema. Trials, record NCT00262301. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00262301
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema
- NCT number
- NCT00262301
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 75 participants, actual
- Lead sponsor
- Pharming Technologies B.V.
- Conditions
- Hereditary Angioedema, Angioneurotic Edema, Genetic Disorders
- Interventions
- recombinant human C1 inhibitor, Placebo
- First posted
- 2005-12-06
- Last updated
- 2012-10-02
- Results first posted
- 2012-08-30
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 | up to 48 hours after study drug administration | The time to beginning of relief of symptoms has been assessed by using a patient-reported visual analogue scale ("VAS") ranging from 0 mm (no symptoms at all) to 100 mm (extremely disabling). Time to beginning of relief of symptoms at the location that showed first "VAS" score decrease of at least 20 mm from baseline score (t= 0 min) to the next assessment time-point). Assessment time-points were taken on pre-scheduled time-points after drug administration: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to beginning of relief has been calculated as median time, by using the exact time-points on which each assessment was performed. |
| Secondary | Time to Minimal Symptoms | up to 48 hours after study drug administration | the time to minimal symptoms was the time to minimal symptoms for an attack, assessed using the Visual Analogue Scale ("VAS") score. Symptoms were said to be minimal when the "VAS" score at all locations was below 20 mm. Assessment time-points were: baseline (0 minutes), 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours, 48 hours. Time to minimal symptoms has been calculated by using the exact time-points on which each assessment was performed. |
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 | up to 48 hours after study drug administration | The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of the study drug administration. | minutes | MEDIAN |
| SECONDARY | Time to Minimal Symptoms | up to 48 hours after study drug administration | The full analysis set (FAS or mITT) was defined as the set of patients who provided Informed Consent, were randomized and took at least one dose of study drug administration. | minutes | 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 Beginning of Relief of Symptoms | 100 IU/kg rhC1INH | 62 | Full Range 15 to 1470 | minutes | |
| Time to Beginning of Relief of Symptoms | Saline | 508 | Full Range 15 to 2880 | minutes | |
| Time to Beginning of Relief of Symptoms | 1 Vial (2100 IU) rhC1INH | 61 | Full Range 15 to 1455 | minutes | |
| Time to Minimal Symptoms | 100 IU/kg rhC1INH | 480 | Full Range 15 to 2400 | minutes | |
| Time to Minimal Symptoms | Saline | 1440 | Full Range 31 to 2885 | minutes | |
| Time to Minimal Symptoms | 1 Vial (2100 IU) rhC1INH | 241 | Full Range 15 to 4333 | minutes |
Source ClinicalTrials.gov
Participant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Phase | STARTED | 100 IU/kg rhC1INH | 16 | |
| Double-blind Phase | STARTED | Saline | 16 | |
| Double-blind Phase | STARTED | 1 Vial (2100 IU) rhC1INH | 0 | |
| Double-blind Phase | COMPLETED | 100 IU/kg rhC1INH | 15 | |
| Double-blind Phase | COMPLETED | Saline | 15 | |
| Double-blind Phase | COMPLETED | 1 Vial (2100 IU) rhC1INH | 0 | |
| Double-blind Phase | NOT COMPLETED | 100 IU/kg rhC1INH | 1 | |
| Double-blind Phase | NOT COMPLETED | Saline | 1 | |
| Double-blind Phase | NOT COMPLETED | 1 Vial (2100 IU) rhC1INH | 0 | |
| Open-label Phase | STARTED | 100 IU/kg rhC1INH | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events27
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 | headache | Nervous system disorders | 100 IU/kg rhC1INH | 1 | 16 | 1 |
| other | headache | Nervous system disorders | Saline | 2 | 16 | 2 |
| other | headache | Nervous system disorders | 1 Vial (2100 IU) rhC1INH | 3 | 57 | 3 |
| other | nausea | Gastrointestinal disorders | 100 IU/kg rhC1INH | 0 | 16 | 0 |
| other | nausea | Gastrointestinal disorders | Saline | 0 | 16 | 0 |
| other | nausea | Gastrointestinal disorders | 1 Vial (2100 IU) rhC1INH | 3 | 57 | 3 |
| other | menstrual disorder | Reproductive system and breast disorders | 100 IU/kg rhC1INH | 1 | 16 | 1 |
| other | menstrual disorder | Reproductive system and breast disorders | Saline | 0 | 16 | 0 |
| other | menstrual disorder | Reproductive system and breast disorders | 1 Vial (2100 IU) rhC1INH | 0 | 57 | 0 |
| other | scrotal swelling | Reproductive system and breast disorders | 100 IU/kg rhC1INH | 1 | 16 | 1 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 100 IU/kg rhC1INH | ||
| Total, all-cause mortality | Saline | ||
| Total, all-cause mortality | 1 Vial (2100 IU) rhC1INH | ||
| Total, other adverse events | 100 IU/kg rhC1INH | 2 | 16 |
| Total, other adverse events | Saline | 5 | 16 |
| Total, other adverse events | 1 Vial (2100 IU) rhC1INH | 6 | 57 |
| Total, serious adverse events | 100 IU/kg rhC1INH | 0 | 16 |
| Total, serious adverse events | Saline | 2 | 16 |
| Total, serious adverse events | 1 Vial (2100 IU) rhC1INH | 0 | 57 |
Source ClinicalTrials.gov
Papers4
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/NCT00262301
GET https://conductscience.org/api/trials/v1/NCT00262301/events?page=2