Trial · NCT02865720
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of study drug administration up to Week 12 | ITT-S set included participants who received any amount of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Abnormalities in Physical Examination Reported as Adverse Events (AEs) | From start of study drug administration up to Week 12 | ITT-S set included participants who received any amount of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Important (PCI) Vital Signs Reported as Adverse Events (AEs) | Baseline up to Week 12 | ITT-S set included participants who received any amount of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Potentially Clinically Important (PCI) Clinical Laboratory Assessments Reported as Adverse Events (AEs) | Baseline up to Week 12 | ITT-S set included participants who received any amount of investigational product. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Concentration of C1 Esterase Inhibitor (C1 INH) Antigen (Protein Volume) at Week 1 | Week 1: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 hours (h) post-dose | Pharmacokinetic (PK) set included all participants with evaluable PK profiles. | Gram per liter (g/L) | MEAN |
| PRIMARY | Concentration of C1 Esterase Inhibitor (C1 INH) Antigen (Protein Volume) at Week 12 | Week 12: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 h post-dose | PK set included all participants with evaluable PK profiles. | gram per liter (g/L) | MEAN |
| PRIMARY | Concentration of Plasma Complement C4 at Week 1 | Week 1: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 h post-dose | Pharmacodynamic (PD) set included all participants with evaluable PD profiles. | Milligram per liter (mg/L) | MEAN |
| PRIMARY | Concentration of Plasma Complement C4 at Week 12 | Week 12: Pre-dose, 0.5, 1, 2, 6, 24, 48, 72 and 96 h post-dose | PD set included all participants with evaluable PD profiles. | mg/L | MEAN |
| PRIMARY | Concentration of Plasma Complement C1q at Week 1 | Baseline (Week 1) | PD set included all participants with evaluable PD profiles. | International units per milliliter | MEAN |
| PRIMARY | Normalized Number of Angioedema Attacks (NNA) Per Month | Baseline up to Week 12 | Full analysis set (FAS) included all participants who had at least 1 post-baseline efficacy assessment. | Angioedema attacks per month | MEAN |
| PRIMARY | Number of Participants With Angioedema Attacks in Different Anatomic Locations | Baseline up to Week 12 | FAS included all participants who had at least 1 post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Average Severity (Intensity) of Angioedema Attacks | Baseline up to Week 12 | FAS included all participants who had at least 1 postbaseline efficacy assessment. | Units on a scale | MEAN |
| PRIMARY | Average Duration of Angioedema Attacks | Baseline up to Week 12 | FAS included all participants who had at least 1 post-baseline efficacy assessment. | Days | MEAN |
| PRIMARY | Normalized Number of Angioedema Attacks (NNA) Per Month Treated With Rescue Medication | Baseline up to Week 12 | FAS included all participants who had at least 1 post-baseline efficacy assessment. | Angioedema attacks per month | MEAN |
| PRIMARY | Number of Participants Achieving Clinical Responder Rate Relative to Historical Data | Baseline up to Week 12 | FAS included all participants who had at least 1 post-baseline efficacy assessment. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Angioedema Quality of Life (AE-QoL) in Treatment Period | Baseline, Week 12 | FAS included all participants who had at least 1 post-baseline efficacy assessment. | Score on a scale | MEAN |
| PRIMARY | Number of Participants With Breakthrough Angioedema Attacks | Baseline up to Week 12 | FAS included all participants who had at least 1 post-baseline efficacy assessment. Number of participants evaluable for this outcome measure was reported. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Time From Attack Onset to Initial Improvement and Complete Resolution | Baseline up to Week 12 | FAS included all participants who had at least 1 post-baseline efficacy assessment. Number of participants evaluable for this outcome were reported. | Hours | MEDIAN |
| PRIMARY | Time From Onset of Attack to Time Treated by CINRYZE | Baseline up to Week 12 | FAS included all participants who had at least 1 postbaseline efficacy assessment. | Hours | MEDIAN |
| PRIMARY | Time From Treatment With CINRYZE to Initial Improvement | Baseline up to Week 12 | FAS included all participants who had at least 1 post-baseline efficacy assessment. | Hours | MEDIAN |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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
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GET https://conductscience.org/api/trials/v1/NCT02865720/outcomes