Trial · NCT01095497
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
NCT01095497, Phase 2, Completed, Shire; results first posted 2012-03-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration. Trials, record NCT01095497. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01095497
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration
- NCT number
- NCT01095497
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 26 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema
- Interventions
- CINRYZE
- First posted
- 2010-03-30
- Last updated
- 2021-07-09
- Results first posted
- 2012-03-08
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | 18 days in each treatment period | |
| Secondary | Mean Change C1 Inhibitor (C1INH) | 18 days in each treatment period | Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration. |
| Secondary | Mean Change C4 Compliment | 18 days in each treatment period | Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration. |
| Secondary | Number of Participants With C1 Inhibitor (INH) Antibodies | 18 days in each treatment period |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | 18 days in each treatment period | Safety Analysis Set | Participants | NUMBER |
| SECONDARY | Mean Change C1 Inhibitor (C1INH) | 18 days in each treatment period | Intent to Treat Population | g/L | MEAN |
| SECONDARY | Mean Change C4 Compliment | 18 days in each treatment period | Intent to Treat Population | mg/L | MEAN |
| SECONDARY | Number of Participants With C1 Inhibitor (INH) Antibodies | 18 days in each treatment period | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group165
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | Intravenous (IV) CINRYZE | Number of subjects with adverse events | 12 | 0.019 | Participants |
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | Subcutaneous (SC) CINRYZE Dose 1 | Number of subjects with adverse events | 10 | 0.027 | Participants |
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | SC CINRYZE Dose 2 | Number of subjects with adverse events | 11 | 0.010 | Participants |
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | Intravenous (IV) CINRYZE | Number of subjects with injection site reactions | 1 | 0.033 | Participants |
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | Subcutaneous (SC) CINRYZE Dose 1 | Number of subjects with injection site reactions | 10 | 0.032 | Participants |
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | SC CINRYZE Dose 2 | Number of subjects with injection site reactions | 11 | 0.010 | Participants |
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | Intravenous (IV) CINRYZE | Number of subjects who discontinued study drug | 1 | Participants | |
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | Subcutaneous (SC) CINRYZE Dose 1 | Number of subjects who discontinued study drug | 0 | Participants | |
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | SC CINRYZE Dose 2 | Number of subjects who discontinued study drug | 0 | Participants | |
| Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study. | Intravenous (IV) CINRYZE | Number of subjects who withdrew from the study | 1 | Participants |
1 to 10 of 165Source ClinicalTrials.gov
See all 165 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Intravenous CINRYZE | STARTED | IV CINRYZE First, Then SC CINRYZE Dose 1 | 14 | |
| Intravenous CINRYZE | STARTED | IV CINRYZE First, Then SC CINRYZE Dose 2 | 12 | |
| Intravenous CINRYZE | COMPLETED | IV CINRYZE First, Then SC CINRYZE Dose 1 | 13 | |
| Intravenous CINRYZE | COMPLETED | IV CINRYZE First, Then SC CINRYZE Dose 2 | 12 | |
| Intravenous CINRYZE | NOT COMPLETED | IV CINRYZE First, Then SC CINRYZE Dose 1 | 1 | |
| Intravenous CINRYZE | NOT COMPLETED | IV CINRYZE First, Then SC CINRYZE Dose 2 | 0 | |
| Subcutaneous CINRYZE | STARTED | IV CINRYZE First, Then SC CINRYZE Dose 1 | 13 | |
| Subcutaneous CINRYZE | STARTED | IV CINRYZE First, Then SC CINRYZE Dose 2 | 12 | |
| Subcutaneous CINRYZE | COMPLETED | IV CINRYZE First, Then SC CINRYZE Dose 1 | 12 | |
| Subcutaneous CINRYZE | COMPLETED | IV CINRYZE First, Then SC CINRYZE Dose 2 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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 | Injection site pain | General disorders | Intravenous (IV) CINRYZE | 0 | 26 | |
| other | Injection site pain | General disorders | Subcutaneous (SC) CINRYZE Dose 1 | 10 | 13 | |
| other | Injection site pain | General disorders | SC CINRYZE Dose 2 | 8 | 12 | |
| other | Hereditary angioedema | Congenital, familial and genetic disorders | Intravenous (IV) CINRYZE | 5 | 26 | |
| other | Hereditary angioedema | Congenital, familial and genetic disorders | Subcutaneous (SC) CINRYZE Dose 1 | 2 | 13 | |
| other | Hereditary angioedema | Congenital, familial and genetic disorders | SC CINRYZE Dose 2 | 0 | 12 | |
| other | Injection site erythema | General disorders | Intravenous (IV) CINRYZE | 0 | 26 | |
| other | Injection site erythema | General disorders | Subcutaneous (SC) CINRYZE Dose 1 | 4 | 13 | |
| other | Injection site erythema | General disorders | SC CINRYZE Dose 2 | 2 | 12 | |
| other | Headache | Nervous system disorders | Intravenous (IV) CINRYZE | 1 | 26 |
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 | Intravenous (IV) CINRYZE | ||
| Total, all-cause mortality | Subcutaneous (SC) CINRYZE Dose 1 | ||
| Total, all-cause mortality | SC CINRYZE Dose 2 | ||
| Total, other adverse events | Intravenous (IV) CINRYZE | 8 | 26 |
| Total, other adverse events | Subcutaneous (SC) CINRYZE Dose 1 | 10 | 13 |
| Total, other adverse events | SC CINRYZE Dose 2 | 11 | 12 |
| Total, serious adverse events | Intravenous (IV) CINRYZE | 0 | 26 |
| Total, serious adverse events | Subcutaneous (SC) CINRYZE Dose 1 | 0 | 13 |
| Total, serious adverse events | SC CINRYZE Dose 2 | 0 | 12 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license 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/NCT01095497
GET https://conductscience.org/api/trials/v1/NCT01095497/results?page=2