Trial · NCT04180163
Outcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 22
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Achieving Attack-Free Status for the Efficacy Evaluation Period of Day 0 Through Day 182 | Day 0 through Day 182 | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | HAE attacks | NUMBER |
| SECONDARY | Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks Requiring Acute Treatment During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | HAE attacks | NUMBER |
| SECONDARY | Number of Moderate or Severe Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | HAE attacks | NUMBER |
| SECONDARY | Number of Participants With Maximum Hereditary Angioedema (HAE) Attack Severity During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of High-Morbidity Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | HAE attacks | NUMBER |
| SECONDARY | Time to First Hereditary Angioedema (HAE) Attack After Day 0 for the Efficacy Evaluation Period | Day 0 through Day 182 | FAS included all participants who received at least 1 dose of IMP. | days | MEDIAN |
| SECONDARY | Time to First Hereditary Angioedema (HAE) Attack After Day 0 for the Efficacy Evaluation Period | Day 70 through Day 182 | FAS included all participants who received at least 1 dose of IMP. | days | MEDIAN |
| SECONDARY | Number of Participants Achieving at Least 50%, 70% and 90% Reduction in the Investigator-Confirmed Normalized Number of Attacks (NNA) Per 4 Weeks Relative to the Run-in Period NNA for Each of Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Normalized Number of Attacks (NNA) <1.0 Per 4 Weeks, <0.75 Per 4 Weeks, <0.50 Per 4 Weeks and <0.25 Per 4 Weeks for Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Attack-Free Status for the Efficacy Evaluation Period Day 0 Through Day 364, Day 70 Through Day 182, and Day 70 Through Day 364 | Day 0 through Day 364, Day 70 through Day 182, and Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. Overall number analyzed are the number of participants who achieved attack-free status during an efficacy evaluation period. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Attack-Free Status for Monthly Increments | At Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12 and 13 | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Achieving Investigator-Confirmed Hereditary Angioedema (HAE) Attack-Free Intervals | Day 0 through Day 182 | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Attack Free Days During Each of the Efficacy Evaluation Periods | Day 0 through Day 182, Day 0 through Day 364, Day 70 through Day 182, Day 70 through Day 364 | FAS included all participants who received at least 1 dose of IMP. | percentage of attack-free days | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) | From first dose of the study drug up to end of study (EOS) (up to Day 392) | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentrations of Lanadelumab | Predose on Days 0, 56, 98, 140, 182, 266, 350, 364, and at any time on Day 378 or 392 | Pharmacokinetic (PK) Set included all participants in the FAS who had at least 1 evaluable post dose PK concentration value. Number analyzed is the number of participants available for analysis at a specific time point. | nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Change From Baseline in Angioedema Quality of Life (AE-QoL) Questionnaire Total Score | Days 0, 28, 56, 98, 126, 154, 182, 266, 364, 378 or 392 | FAS included all participants who received at least 1 dose of IMP. | score on a scale | MEAN |
| SECONDARY | Plasma Kallikrein (pKal) Activity | Predose on Days 0, 56, 98, 140, 182, 266, 350, 364, and at any time on Day 378 or 392 | Pharmacodynamic (PD) Set included all participants in the FAS who had at least 1 evaluable post dose PD value. Number analyzed is the number of participants with data available for analysis at the given time point. | percentage of cHMWK | MEAN |
| SECONDARY | Number of Participants With Positive Anti-drug Antibody (ADA) in Plasma | Predose on Days 0 (or Baseline), 56, 98, 140, 182, 266, 350, 364, and at any time on Day 378 or 392 | FAS included all participants who received at least 1 dose of IMP. Number analyzed is the number of participants with data available for analysis at the given time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With TEAEs Related to Clinical Laboratory Tests | From first dose of the study drug up to end of study (EOS) (up to Day 392) | FAS included all participants who received at least 1 dose of IMP. | Participants | COUNT_OF_PARTICIPANTS |
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.
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