Trial · NCT03401671
Outcomes18
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 18 of 18
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | Pharmacokinetic (PK) set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | microgram per milliliter (ug/mL) | GEOMETRIC_MEAN |
| PRIMARY | Time to Reach Maximum Observed Drug Concentration in Plasma (Tmax) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day | MEDIAN |
| PRIMARY | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day*microgram per milliliter(day*ug/mL) | GEOMETRIC_MEAN |
| PRIMARY | Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day*microgram per milliliter(day* ug/mL) | GEOMETRIC_MEAN |
| PRIMARY | Terminal Elimination Rate Constant (Lambda z) for Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | per day | GEOMETRIC_MEAN |
| PRIMARY | Terminal Half-life (t12) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day | MEDIAN |
| PRIMARY | Apparent Clearance (CL/F) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | liter per day | GEOMETRIC_MEAN |
| PRIMARY | Apparent Volume of Distribution (Vz/F) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | liter | GEOMETRIC_MEAN |
| PRIMARY | Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-last) in Plasma of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day*ug/mL/kg | GEOMETRIC_MEAN |
| PRIMARY | Body-weight Adjusted Area Under the Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) in Plasma of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | day*ug/mL/kg | GEOMETRIC_MEAN |
| PRIMARY | Body-weight Adjusted Maximum Observed Plasma Concentration (Cmax) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | microgram per milliliter per kilogram | MEDIAN |
| PRIMARY | Body-weight Adjusted Apparent Clearance (CL/F) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | liter per day per kilogram (L/day/kg) | GEOMETRIC_MEAN |
| PRIMARY | Body-weight Adjusted Apparent Volume of Distribution (Vz/F) of Lanadelumab | Pre-dose, 8, 24, 48, 72, 96, 168, 336, 504, 672, 1008, 1344, 2016 and 2688 hours post-dose | PK set consisted of all participants who received at least 1 dose of lanadelumab and had at least 1 evaluable post-dose PK concentration value. | liter per kilogram (L/kg) | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) Based on Severity, Seriousness and Causality | From start of study drug administration up to follow-up (up to 115 days) | Safety analysis set included all participants who received at least 1 dose of Lanadelumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Change in Clinical Laboratory Results Reported as an Adverse Event | From start of study drug administration up to follow-up (up to 115 days) | Safety analysis set included all participants who received at least 1 dose of Lanadelumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Change in Vital Signs Reported as an Adverse Event | From start of study drug administration up to follow-up (up to 115 days) | Safety analysis set included all participants who received at least 1 dose of Lanadelumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Reported as an Adverse Event | From start of study drug administration up to follow-up (up to 115 days) | Safety analysis set includes all participants who received at least 1 dose of Lanadelumab. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants Who Developed Antidrug Antibodies to Lanadelumab at Specified Time Points | Day 1, 14, 28, 56, and 112 (End of Study/Early Termination [EOS/ET]) | Safety analysis set included all participants who received at least 1 dose of lanadelumab. | 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.
For software
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GET https://conductscience.org/api/trials/v1/NCT03401671/outcomes