Trial · NCT06679426
Safety and Efficacy of Conestat Alfa for ACE-Induced Angioedema
NCT06679426, Phase 3, Unknown, University of Cincinnati
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Safety and Efficacy of Conestat Alfa for ACE-Induced Angioedema. Trials, record NCT06679426. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06679426
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Conestat Alfa for ACE-Induced Angioedema
- NCT number
- NCT06679426
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 24 participants, estimated
- Lead sponsor
- University of Cincinnati
- Conditions
- ACE Inhibitor-Induced Angioedema
- Interventions
- Conestat Alfa
- First posted
- 2024-11-07
- Last updated
- 2024-11-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The primary objective is to assess the efficacy of conestat alfa compared to placebo in the treatment of ACE-1-induced AE based on the Time to Onset of Symptom Relief (TOSR) endpoint. | 24 hours | The TOSR is defined as the time at which the total severity score of four airway compromising symptoms (difficulty breathing, difficulty swallowing, voice changes, and tongue swelling) has decreased by at least 1 point overall and no individual component of the score has increased. The 5-point severity scale is: 0 = absence of symptoms, 1 = mild, 2 = moderate, 3 = severe, 4 = very severe. |
| Secondary | The secondary objective is to compare the efficacy of conestat alfa to placebo for the treatment of ACE-1-induced AE based on the endpoint of Time to Meeting Discharge Criteria (TMDC). | 24 hours | The criteria for discharge will be based on the assessment of the severity of four airway compromising symptoms, and will be calculated from the time of initiation of study drug administration to the earliest point at which the symptoms of difficulty breathing and difficulty swallowing have resolved (score = 0) and the symptoms of voice change and tongue swelling are mild or absent. |
| Other | Exploratory objective | 24 hours | Exploratory objectives include comparison of the proportion of patients in each arm who 1) are hospitalized to any level of care 2) are admitted to the intensive care unit (ICU) and 3) required an airway intervention (e.g., intubation, cricothyrotomy, or tracheotomy). |
| Other | Safety outcome | Every hour post treatment up to 8 hours and then every 2 hours from >8 to 24 hours; phone calls at day 7 and day 28. | Safety and tolerability of conestat alfa treatment in patients experiencing ACE-I-induced AE will be assessed. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers6
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/NCT06679426
GET https://conductscience.org/api/trials/v1/NCT06679426/registered