Trial · NCT01467947
Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert
NCT01467947, Phase 4, Completed, CSL Behring; results first posted 2015-11-16
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert. Trials, record NCT01467947. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01467947
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert
- NCT number
- NCT01467947
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 46 participants, actual
- Lead sponsor
- CSL Behring
- Conditions
- Hereditary Angioedema Types I and II
- Interventions
- Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection
- First posted
- 2011-11-09
- Last updated
- 2017-02-06
- Other registries' IDs
- eudract:2010-024242-30
- Results first posted
- 2015-11-16
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies | Baseline to approximately 9 months | Subjects with no positive baseline result and at least one positive post-baseline result for inhibitory anti-C1-INH antibodies. |
| Secondary | Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies | Baseline to approximately 9 months | Subjects with at least one positive result for inhibitory or non-inhibitory anti-C1-INH antibodies. |
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 | Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies | Baseline to approximately 9 months | subjects | NUMBER | |
| SECONDARY | Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies | Baseline to approximately 9 months | Subjects | NUMBER |
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 |
|---|---|---|---|---|---|
| Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies | C1 Esterase Inhibitor | 0 | subjects | ||
| Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies | C1 Esterase Inhibitor | Antibodies detected on Day 1 (Baseline) | 9 | Subjects | |
| Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies | C1 Esterase Inhibitor | Antibodies detected post-baseline | 10 | Subjects | |
| Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies | C1 Esterase Inhibitor | Antibodies first detected at Month 3 | 2 | Subjects | |
| Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies | C1 Esterase Inhibitor | Antibodies first detected at Month 6 | 1 | Subjects | |
| Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies | C1 Esterase Inhibitor | Antibodies first detected at Month 9 | 1 | Subjects |
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 | 46 | |
| Overall Study | COMPLETED | C1 Esterase Inhibitor | 46 | |
| Overall Study | NOT COMPLETED | C1 Esterase Inhibitor | 0 |
Source ClinicalTrials.gov
Adverse events4
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 | Hypotension | Vascular disorders | C1 Esterase Inhibitor | 3 | 46 | 3 |
| other | Headache | Nervous system disorders | C1 Esterase Inhibitor | 6 | 46 | 26 |
| serious | Hereditary angioedema | Congenital, familial and genetic disorders | C1 Esterase Inhibitor | 1 | 46 | 1 |
| serious | Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | C1 Esterase Inhibitor | 1 | 46 | 1 |
Source ClinicalTrials.gov
Adverse 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 | 7 | 46 |
| Total, serious adverse events | C1 Esterase Inhibitor | 2 | 46 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 27788880 | 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/NCT01467947
GET https://conductscience.org/api/trials/v1/NCT01467947/registered