Trial · NCT04070326
A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
NCT04070326, Phase 3, Completed, Shire; results first posted 2022-05-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children. Trials, record NCT04070326. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04070326
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Lanadelumab to Prevent Hereditary Angioedema (HAE) Attacks in Children
- NCT number
- NCT04070326
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 21 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema
- Interventions
- Lanadelumab
- First posted
- 2019-08-28
- Last updated
- 2022-05-26
- Other registries' IDs
- eudract:2018-002093-42
- Results first posted
- 2022-05-26
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Up to approximately 115 weeks | An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this investigational product or medicinal product. A SAE is any untoward clinical manifestation of signs, symptoms or outcomes (whether considered related to investigational product or not and at any dose which results in death, is life-threatening, requires inpatient hospitalization or prolongation of hospitalization, results in persistent or significant disability/incapacity, results in a congenital abnormality/birth defect, is an important medical event. Adverse events of special interest for this study are hypersensitivity reactions and disordered coagulation (hypercoagulability events and bleeding events). |
| Primary | Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Up to approximately 115 weeks | Laboratory values (chemistry, hematology, and coagulation) were to be considered clinically significant based on investigator's discretion. |
| Primary | Number of Participants With Clinically Significant Vital Signs Measurements | Up to approximately 115 weeks | Vital signs included blood pressure, heart rate, body temperature, and respiratory rate. |
| 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 plasma concentration of lanadelumab over treatment period was assessed. |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group320
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Lanadelumab 150 mg, q4wks | SAEs | 0 | Participants | |
| Number of Participants With Adverse Events Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Lanadelumab 150 mg, q2wks | SAEs | 0 | Participants | |
| Number of Participants With Adverse Events Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Lanadelumab 150 mg, q4wks | AESIs | 0 | Participants | |
| Number of Participants With Adverse Events Including Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) | Lanadelumab 150 mg, q2wks | AESIs | 0 | Participants | |
| Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Lanadelumab 150 mg: Age 2 to <6 Years | 0 | Participants | ||
| Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Lanadelumab 150 mg: Age 6 to <12 Years | 0 | Participants | ||
| Number of Participants With Clinically Significant Vital Signs Measurements | Lanadelumab 150 mg: Age 2 to <6 Years | 0 | Participants | ||
| Number of Participants With Clinically Significant Vital Signs Measurements | Lanadelumab 150 mg: Age 6 to <12 Years | 0 | Participants | ||
| Plasma Concentrations of Lanadelumab Over The Treatment Period | Lanadelumab 150 mg: Age 2 to <6 Years | Visit 1 Day 0 | 0.000 | Standard Deviation 0.0000 | nanograms per milliliter (ng/mL) |
| Plasma Concentrations of Lanadelumab Over The Treatment Period | Lanadelumab 150 mg: Age 6 to <12 Years | Visit 1 Day 0 | 11.735 | Standard Deviation 39.2984 | nanograms per milliliter (ng/mL) |
1 to 10 of 320Source ClinicalTrials.gov
See all 320 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Baseline Observation-12 Weeks Before TP | STARTED | Lanadelumab 150 mg: Age 2 to <6 Years | 4 | |
| Baseline Observation-12 Weeks Before TP | STARTED | Lanadelumab 150 mg: Age 6 to <12 Years | 17 | |
| Baseline Observation-12 Weeks Before TP | COMPLETED | Lanadelumab 150 mg: Age 2 to <6 Years | 4 | |
| Baseline Observation-12 Weeks Before TP | COMPLETED | Lanadelumab 150 mg: Age 6 to <12 Years | 17 | |
| Baseline Observation-12 Weeks Before TP | NOT COMPLETED | Lanadelumab 150 mg: Age 2 to <6 Years | 0 | |
| Baseline Observation-12 Weeks Before TP | NOT COMPLETED | Lanadelumab 150 mg: Age 6 to <12 Years | 0 | |
| Treatment Period A (Weeks 1 to 26) | STARTED | Lanadelumab 150 mg: Age 2 to <6 Years | 4 | |
| Treatment Period A (Weeks 1 to 26) | STARTED | Lanadelumab 150 mg: Age 6 to <12 Years | 17 | |
| Treatment Period A (Weeks 1 to 26) | COMPLETED | Lanadelumab 150 mg: Age 2 to <6 Years | 3 | |
| Treatment Period A (Weeks 1 to 26) | COMPLETED | Lanadelumab 150 mg: Age 6 to <12 Years | 17 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events112
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diplopia | Eye disorders | Lanadelumab 150 mg, q4wks | 0 | 11 | 0 |
| other | Diplopia | Eye disorders | Lanadelumab 150 mg, q2wks | 1 | 18 | 1 |
| other | Eye inflammation | Eye disorders | Lanadelumab 150 mg, q4wks | 0 | 11 | 0 |
| other | Eye inflammation | Eye disorders | Lanadelumab 150 mg, q2wks | 1 | 18 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Lanadelumab 150 mg, q4wks | 1 | 11 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Lanadelumab 150 mg, q2wks | 2 | 18 | 3 |
| other | Tooth loss | Gastrointestinal disorders | Lanadelumab 150 mg, q4wks | 0 | 11 | 0 |
| other | Tooth loss | Gastrointestinal disorders | Lanadelumab 150 mg, q2wks | 1 | 18 | 2 |
| other | Abdominal pain upper | Gastrointestinal disorders | Lanadelumab 150 mg, q4wks | 0 | 11 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | Lanadelumab 150 mg, q2wks | 1 | 18 | 1 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Lanadelumab 150 mg, q4wks | 0 | 11 |
| Total, all-cause mortality | Lanadelumab 150 mg, q2wks | 0 | 18 |
| Total, other adverse events | Lanadelumab 150 mg, q4wks | 6 | 11 |
| Total, other adverse events | Lanadelumab 150 mg, q2wks | 15 | 18 |
| Total, serious adverse events | Lanadelumab 150 mg, q4wks | 0 | 11 |
| Total, serious adverse events | Lanadelumab 150 mg, q2wks | 0 | 18 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37730089 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Lanadelumab 150 mg: Age 2 to <6 Years vs Lanadelumab 150 mg: Age 6 to <12 Years: Number of Participants With Clinically Significant Vital Signs Measurements | Trial comparisons |
| Lanadelumab 150 mg: Age 2 to <6 Years vs Lanadelumab 150 mg: Age 6 to <12 Years: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities | Trial comparisons |
| Lanadelumab 150 mg, q4wks vs Lanadelumab 150 mg, q2wks: deaths from any cause | Trial comparisons |
| Lanadelumab 150 mg, q4wks vs Lanadelumab 150 mg, q2wks: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04070326
GET https://conductscience.org/api/trials/v1/NCT04070326/registered?page=2