Trial · NCT01576523
A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route
NCT01576523, Phase 1, Phase 2, Completed, CSL Behring; results first posted 2021-02-01
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route. Trials, record NCT01576523. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01576523
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route
- NCT number
- NCT01576523
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 18 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Hereditary Angioedema Types I and II
- Interventions
- C1-esterase inhibitor - single intravenous dose, C1-esterase inhibitor - subcutaneous low dose, C1-esterase inhibitor - subcutaneous medium dose, C1-esterase inhibitor - subcutaneous high dose
- First posted
- 2012-04-12
- Last updated
- 2021-02-01
- Other registries' IDs
- eudract:2011-005013-36
- Results first posted
- 2021-02-01
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Modeled C1-esterase Inhibitor Functional Activity Trough Level | at the fourth week of each dosing regimen | Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens, based on modeling and simulation |
| Secondary | As-observed C1-esterase Inhibitor Functional Activity Trough Level | during the last week of 4-week dose regimen | Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens |
| Secondary | C1-esterase Inhibitor Concentration Trough Level | during the last week of 4-week dose regimen | Mean trough C1-esterase inhibitor concentration of the low, medium and high subcutaneous dose regimens |
| Secondary | C4 Concentration Trough Level | during the last week of 4-week dose regimen | Mean trough C4 concentration of the low, medium and high subcutaneous dose regimens |
| Secondary | Change From Baseline in C1-esterase Inhibitor Functional Activity | Baseline and during the last week of 4-week dose regimen | Mean change from baseline of C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens |
| Secondary | Change From Baseline in C1-esterase Inhibitor Concentration | Baseline and during the last week of 4-week dose regimen | Mean change from baseline of C1-esterase inhibitor concentration of the low, medium and high subcutaneous dose regimens |
| Secondary | Change From Baseline in C4 Concentration | Baseline and during the last week of 4-week dose regimen | Mean change from baseline of C4 concentration of the low, medium and high subcutaneous dose regimens |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Modeled C1-esterase Inhibitor Functional Activity Trough Level | at the fourth week of each dosing regimen | Complete Analysis Set (CAS) - Subjects received at least 1 dose (complete or incomplete) of the dosing regimen of CSL830 and provided at least 1 C1-INH functional activity measurement during the dosing regimen (prior to the use of any prohibited concomitant therapy or prohibited change in dosage of a concomitant therapy) | percent functional activity | MEAN |
| SECONDARY | As-observed C1-esterase Inhibitor Functional Activity Trough Level | during the last week of 4-week dose regimen | As-observed analysis set - subset of the full analysis set (FAS). FAS consisted of all enrolled subjects (all subjects who gave informed consent). | percent functional activity | MEAN |
| SECONDARY | C1-esterase Inhibitor Concentration Trough Level | during the last week of 4-week dose regimen | As-observed analysis set | mg/mL | MEAN |
| SECONDARY | C4 Concentration Trough Level | during the last week of 4-week dose regimen | As-observed analysis set | mg/dL | MEAN |
| SECONDARY | Change From Baseline in C1-esterase Inhibitor Functional Activity | Baseline and during the last week of 4-week dose regimen | As-observed analysis set | percent functional activity | MEAN |
| SECONDARY | Change From Baseline in C1-esterase Inhibitor Concentration | Baseline and during the last week of 4-week dose regimen | As-observed analysis set | mg/mL | MEAN |
| SECONDARY | Change From Baseline in C4 Concentration | Baseline and during the last week of 4-week dose regimen | As-observed analysis set | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Modeled C1-esterase Inhibitor Functional Activity Trough Level | CSL830 (Low Dose) | 30.3 | Standard Deviation 9.07 | percent functional activity | |
| Modeled C1-esterase Inhibitor Functional Activity Trough Level | CSL830 (Medium Dose) | 45.9 | Standard Deviation 14.35 | percent functional activity | |
| Modeled C1-esterase Inhibitor Functional Activity Trough Level | CSL830 (High Dose) | 80.6 | Standard Deviation 23.47 | percent functional activity | |
| As-observed C1-esterase Inhibitor Functional Activity Trough Level | CSL830 (Low Dose) | 31.7 | Standard Deviation 9.97 | percent functional activity | |
| As-observed C1-esterase Inhibitor Functional Activity Trough Level | CSL830 (Medium Dose) | 44.3 | Standard Deviation 17.73 | percent functional activity | |
| As-observed C1-esterase Inhibitor Functional Activity Trough Level | CSL830 (High Dose) | 80.5 | Standard Deviation 24.92 | percent functional activity | |
| C1-esterase Inhibitor Concentration Trough Level | CSL830 (Low Dose) | 0.06 | Standard Deviation 0.024 | mg/mL | |
| C1-esterase Inhibitor Concentration Trough Level | CSL830 (Medium Dose) | 0.15 | Standard Deviation 0.130 | mg/mL | |
| C1-esterase Inhibitor Concentration Trough Level | CSL830 (High Dose) | 0.23 | Standard Deviation 0.158 | mg/mL | |
| C4 Concentration Trough Level | CSL830 (Low Dose) | 11.1 | Standard Deviation 4.45 | mg/dL |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dosing Period 1 | STARTED | Low, Then Medium, CSL830 Dose | 3 | |
| Dosing Period 1 | STARTED | Medium, Then Low, CSL830 Dose | 3 | |
| Dosing Period 1 | STARTED | Medium, Then High, CSL830 Dose | 3 | |
| Dosing Period 1 | STARTED | Low, Then High, CSL830 Dose | 3 | |
| Dosing Period 1 | STARTED | High, Then Low, CSL830 Dose | 3 | |
| Dosing Period 1 | STARTED | High, Then Medium, CSL830 Dose | 3 | |
| Dosing Period 1 | COMPLETED | Low, Then Medium, CSL830 Dose | 3 | |
| Dosing Period 1 | COMPLETED | Medium, Then Low, CSL830 Dose | 3 | |
| Dosing Period 1 | COMPLETED | Medium, Then High, CSL830 Dose | 3 | |
| Dosing Period 1 | COMPLETED | Low, Then High, CSL830 Dose | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events212
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 | Injection site erythema | General disorders | Berinert | 0 | 18 | 0 |
| other | Injection site erythema | General disorders | CSL830 (Low Dose) | 2 | 12 | 5 |
| other | Injection site erythema | General disorders | CSL830 (Medium Dose) | 2 | 12 | 3 |
| other | Injection site erythema | General disorders | CSL830 (High Dose) | 5 | 12 | 19 |
| other | Injection site pain | General disorders | Berinert | 0 | 18 | 0 |
| other | Injection site pain | General disorders | CSL830 (Low Dose) | 5 | 12 | 13 |
| other | Injection site pain | General disorders | CSL830 (Medium Dose) | 0 | 12 | 0 |
| other | Injection site pain | General disorders | CSL830 (High Dose) | 2 | 12 | 12 |
| other | Injection site swelling | General disorders | Berinert | 0 | 18 | 0 |
| other | Injection site swelling | General disorders | CSL830 (Low Dose) | 1 | 12 | 1 |
1 to 10 of 212Source ClinicalTrials.gov
See all 212 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Berinert | 0 | 18 |
| Total, all-cause mortality | CSL830 (Low Dose) | 0 | 12 |
| Total, all-cause mortality | CSL830 (Medium Dose) | 0 | 12 |
| Total, all-cause mortality | CSL830 (High Dose) | 0 | 12 |
| Total, other adverse events | Berinert | 4 | 18 |
| Total, other adverse events | CSL830 (Low Dose) | 10 | 12 |
| Total, other adverse events | CSL830 (Medium Dose) | 8 | 12 |
| Total, other adverse events | CSL830 (High Dose) | 9 | 12 |
| Total, serious adverse events | Berinert | 1 | 18 |
| Total, serious adverse events | CSL830 (Low Dose) | 0 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 26016741 | RESULT |
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 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/NCT01576523
GET https://conductscience.org/api/trials/v1/NCT01576523/results?page=2