Trial · NCT04070326
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 With Adverse Events Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Up to approximately 115 weeks | The Safety Analysis Set consisted of all participants who received study drug. Overall number analyzed are participants presented by the actual treatment regimen. Because of dose modifications, some participants were treated with both dosing regimens and were counted in both treatment groups. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Up to approximately 115 weeks | The Safety Analysis Set consisted of all participants who received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Vital Signs Measurements | Up to approximately 115 weeks | The Safety Analysis Set consisted of all participants who received study drug. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Plasma Concentrations of Lanadelumab Over The Treatment Period | Day 0 (Pre-dose), Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392 | The Pharmacokinetic (PK) Set included all participants in the Safety Analysis Set who have at least 1 evaluable post dose PK concentration value. Number analyzed is the number of participants with data available for analysis at the given timepoint. | nanograms per milliliter (ng/mL) | MEAN |
| PRIMARY | Maximum Observed Concentration at Steady State (Cmax,ss) of Lanadelumab in Plasma | Day 0 (Pre-dose), at any time pre-dose on Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392 | The PK Set included all participants in the Safety Analysis Set who have at least 1 evaluable post dose PK concentration value. | micrograms per mL (μg/mL) | GEOMETRIC_MEAN |
| PRIMARY | Average Concentration Over Dosing Interval at Steady State (Cavg,ss) of Lanadelumab in Plasma | Day 0 (Pre-dose), at any time pre-dose on Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392 | The PK Set included all participants in the Safety Analysis Set who have at least 1 evaluable post dose PK concentration value. | μg/mL | GEOMETRIC_MEAN |
| PRIMARY | Minimum Concentration at Steady State (Cmin,ss) of Lanadelumab in Plasma | Day 0 (Pre-dose), at any time pre-dose on Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392 | The PK Set included all participants in the Safety Analysis Set who have at least 1 evaluable post dose PK concentration value. | µg/mL | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Maximum Observed Concentration (Cmax) [Tmax] of Lanadelumab in Plasma | Day 0 (Pre-dose), at any time pre-dose on Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392 | The PK Set included all participants in the Safety Analysis Set who have at least 1 evaluable post dose PK concentration value. | hours (h) | MEDIAN |
| PRIMARY | Area Under the Concentration-Time Curve Over the Dosing Interval at Steady State (AUCtau,ss) of Lanadelumab in Plasma | Day 0 (Pre-dose), at any time pre-dose on Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392 | The PK Set included all participants in the Safety Analysis Set who have at least 1 evaluable post dose PK concentration value. | μg.day/mL | GEOMETRIC_MEAN |
| PRIMARY | Terminal Half-life (t1/2) of Lanadelumab in Plasma | Day 0 (Pre-dose), at any time pre-dose on Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392 | The PK Set included all participants in the Safety Analysis Set who have at least 1 evaluable post dose PK concentration value. | days | MEDIAN |
| PRIMARY | Apparent Clearance (CL/F) of Lanadelumab | Day 0 (Pre-dose), at any time pre-dose on Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392 | The PK Set included all participants in the Safety Analysis Set who have at least 1 evaluable post dose PK concentration value. | L/h | GEOMETRIC_MEAN |
| PRIMARY | Apparent Volume of Distribution (V/F) of Lanadelumab | Day 0 (Pre-dose), at any time pre-dose on Day 4, 14, 28, 56, 84, 112, 140, 168, 182 196, 252, 308, 364 and 392 | The PK Set included all participants in the Safety Analysis Set who have at least 1 evaluable post dose PK concentration value. | L | GEOMETRIC_MEAN |
| SECONDARY | Normalized Number of Investigator-Confirmed Hereditary Angioedema (HAE) Attacks During Overall Treatment Period | Day 0 (after start of study drug administration) through Day 364 (Week 52) | The Safety Analysis Set consisted of all participants who received study drug. Overall number analyzed are participants presented by the actual treatment regimen. Because of dose modifications, some participants were treated with both dosing regimens and were counted in both treatment groups. | HAE attacks per month | MEAN |
| SECONDARY | Normalized Number of Investigator-Confirmed HAE Attacks For Each Efficacy Evaluation Period Other Than the Overall Treatment Period | Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364 | The Safety Analysis Set consisted of all participants who received study drug. Overall number analyzed are participants presented by the actual treatment regimen. Because of dose modifications, some participants were treated with both dosing regimens and were counted in both treatment groups. | HAE attacks per month | MEAN |
| SECONDARY | Time to the First Investigator-Confirmed HAE Attack for Each Evaluation Period | Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364 | The Safety Analysis Set consisted of all participants who received study drug. Overall number analyzed are participants presented by the actual treatment regimen. Because of dose modifications, some participants were treated with both dosing regimens and were counted in both treatment groups. | days | MEDIAN |
| SECONDARY | Normalized Number of HAE Attacks Requiring Acute Treatment for Each Efficacy Evaluation Period | Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364 | The Safety Analysis Set consisted of all participants who received study drug. Overall number analyzed are participants presented by the actual treatment regimen. Because of dose modifications, some participants were treated with both dosing regimens and were counted in both treatment groups. | HAE attacks per month | MEAN |
| SECONDARY | Normalized Number of Moderate or Severe Investigator-Confirmed HAE Attacks for Each Efficacy Evaluation Period | Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364 | The Safety Analysis Set consisted of all participants who received study drug. Overall number analyzed are participants presented by the actual treatment regimen. Because of dose modifications, some participants were treated with both dosing regimens and were counted in both treatment groups. | HAE attacks per month | MEAN |
| SECONDARY | Normalized Number of High Morbidity Investigator-Confirmed HAE Attacks for Each Efficacy Evaluation Period | Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364 | The Safety Analysis Set consisted of all participants who received study drug. Overall number analyzed are participants presented by the actual treatment regimen. Because of dose modifications, some participants were treated with both dosing regimens and were counted in both treatment groups. | HAE attacks per month | MEAN |
| SECONDARY | Number of Participants With Characteristics of Investigator-Confirmed HAE Attacks for Each Efficacy Evaluation Period | Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364 | The Safety Analysis Set consisted of all participants who received study drug. Overall number analyzed are participants presented by the actual treatment regimen. Because of dose modifications, some participants were treated with both dosing regimens and were counted in both treatment groups. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With HAE Attack-Free Status for Each Evaluation Period | Day 0 through Day 364, Day 0 through Day 182, Day 70 through Day 182, Day 183 through Day 364, Day 70 through Day 364 | The Safety Analysis Set consisted of all participants who received study drug. Overall number analyzed are participants presented by the actual treatment regimen. Because of dose modifications, some participants were treated with both dosing regimens and were counted in both treatment groups. | 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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