Trial · NCT04444895
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) During Treatment Period | From Day 0 up to Day 182 | The SFAS included all participants who received any study drug after entering this study (i.e., any exposure to open-label lanadelumab). The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) During Follow-up | From Day 183 up to Day 196 | The SFAS included all participants who received any study drug after entering this study (i.e., any exposure to open-label lanadelumab). The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | From Day 0 up to Day 182 | The SFAS included all participants who received any study drug after entering this study (i.e., any exposure to open-label lanadelumab). The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen. | angioedema attacks | NUMBER |
| SECONDARY | Number of Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | From Day 0 up to Day 182 | The SFAS included all participants who received any study drug after entering this study (i.e., any exposure to open-label lanadelumab). The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen. | angioedema attacks | NUMBER |
| SECONDARY | Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 | From Day 0 up to Day 182 | The SFAS included all participants who received any study drug after entering this study (i.e., any exposure to open-label lanadelumab). The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen. | angioedema attacks | NUMBER |
| SECONDARY | Pharmacokinetic (PK) Plasma Concentrations of Lanadelumab | Predose on Days 0, 84, and 140 and postdose on Day 182 | The Pharmacokinetic (PK) Set included all participants in the SFAS who had at least 1 evaluable postdose PK concentration value. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | nanograms per milliliter (ng/mL) | MEAN |
| SECONDARY | Plasma Kallikrein (pKal) Activity | Predose on Days 0, 84, and 140 and postdose on Day 182 | The Pharmacodynamic (PD) Set included all participants in the SFAS who had at least 1 evaluable postdose PD concentration value. Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | percentage of cHMWK | MEAN |
| SECONDARY | Number of Participants With Neutralizing Antidrug Antibodies (ADA) in Plasma | Predose on Days 0, 84, and 140 and postdose on Day 182 | The SFAS included all participants who received any study drug after entering this study (i.e., any exposure to open-label lanadelumab). Overall number analyzed is the number of participants with data available for analyses. Number analyzed is the number of participants with data available for analysis at the specified time point. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Total Angioedema Quality of Life (AE-QoL) Questionnaire Total Score at End of Treatment Period | Baseline (Day 0) up to end of treatment period (Day 182) | The SFAS included all participants who received any study drug after entering this study (i.e., any exposure to open-label lanadelumab). Overall number analyzed is the number of participants with data available for analyses. | score on a scale | MEAN |
| SECONDARY | Number of Participants With Any Pause During Injection | Days 0, 14, 28, 42, 56, 70, 84, 98, 112, 126, 140, 154, and 168 | The SFAS included all participants who received any study drug after entering this study (i.e., any exposure to open-label lanadelumab). Number analyzed is the number of participants with data available for analysis at the specified time point. The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events (TEAEs) Including Adverse Events of Special Interest (AESI) and Serious Adverse Events (SAEs) in Participants Who Switched Dosing Regimen | From Day 0 up to Day 196 | The RD-SFAS Set was a subset of the SFAS Set and included participants who switched from lanadelumab 300 mg Q2W to a lanadelumab 300 mg Q4W dosing regimen as recorded on the Dose Frequency Modification electronic case report form. The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Investigator-Confirmed Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 in Participants Who Switched Dosing Regimen | From Day 0 up to Day 182 | The RD-SFAS Set was a subset of the SFAS Set and included participants who switched from lanadelumab 300 mg Q2W to a lanadelumab 300 mg Q4W dosing regimen as recorded on the Dose Frequency Modification electronic case report form. The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen. | angioedema attacks | NUMBER |
| SECONDARY | Number of Moderate or Severe Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 in Participants Who Switched Dosing Regimen | From Day 0 up to Day 182 | The RD-SFAS Set was a subset of the SFAS Set and included participants who switched from lanadelumab 300 mg Q2W to a lanadelumab 300 mg Q4W dosing regimen as recorded on the Dose Frequency Modification electronic case report form. The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen. | angioedema attacks | NUMBER |
| SECONDARY | Number of High-Morbidity Angioedema Attacks During the Treatment Period of Day 0 Through Day 182 in Participants Who Switched Dosing Regimen | From Day 0 up to Day 182 | The RD-SFAS Set was a subset of the SFAS Set and included participants who switched from lanadelumab 300 mg Q2W to a lanadelumab 300 mg Q4W dosing regimen as recorded on the Dose Frequency Modification electronic case report form. The data was partitioned by dosing regimen and reported accordingly to appropriately attribute to each dosing regimen. | angioedema attacks | NUMBER |
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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