Trial · NCT01386658
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
NCT01386658, Phase 3, Completed, Shire; results first posted 2019-03-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema. Trials, record NCT01386658. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01386658
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
- NCT number
- NCT01386658
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 32 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hereditary Angioedema (HAE)
- Interventions
- icatibant
- First posted
- 2011-07-01
- Last updated
- 2021-06-08
- Other registries' IDs
- eudract:2011-003825-81
- Results first posted
- 2019-03-25
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | Time to peak concentration (Tmax) of a single SC dose of icatibant was reported. |
| Primary | Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | Maximum plasma concentration (Cmax) of a single SC dose of icatibant was reported. |
| Primary | Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | Total plasma clearance (CL/F) of a single SC dose of icatibant was reported. |
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, and 4 hours post-dose on Day 1 | Area under the plasma concentration-time curve from time zero to 4 hours post-dose (AUC0-4) of a single SC dose of icatibant was reported. |
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours Post-dose (AUC0-t) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | Area under the plasma concentration-time curve from time zero to 6 hours post-dose (AUC0-t) of a single SC dose of icatibant was reported. |
| Primary | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | Area under the plasma concentration-time curve from time zero to infinity (AUC0-inf) of a single SC dose of icatibant was reported. |
| Primary | Volume of Distribution (Vz/F) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | Volume of distribution (Vz/F) of a single SC dose of icatibant was reported. |
| Primary | Elimination Half-life (t1/2) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | Elimination half-life (t1/2) of a single SC dose of icatibant was reported. |
| Primary | Number of Participants With Clinically Significant Changes in Vital Signs | Pre-dose up to 97 days post-dose | Vital signs included pulse rate, blood pressure, respiration rate, and temperature. The number of participants who reported clinically significant changes in vital signs were reported. |
| Primary | Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs) | 6 - 8 hours post-dose on Day 1 | A standard 12-lead ECG was performed after 10 minutes at rest when the participant was seated or supine following treatment. The number of participants who reported clinically significant changes in ECGs were reported. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | Pharmacokinetic (PK) population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Hour (h) | MEAN |
| PRIMARY | Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration-time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Nanogram per milliliter (ng/mL) | MEAN |
| PRIMARY | Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Milliliters per minute (mL/min) | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, and 4 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Hour*nanogram per milliliter (h*ng/mL) | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From Time Zero to 6 Hours Post-dose (AUC0-t) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | h*ng/mL | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | h*ng/mL | MEAN |
| PRIMARY | Volume of Distribution (Vz/F) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | Liters (L) | MEAN |
| PRIMARY | Elimination Half-life (t1/2) of a Single Subcutaneous (SC) Dose of Icatibant | Pre-dose; 0.25, 0.5, 0.75, 1, 2, 4 and 6 hours post-dose on Day 1 | The PK population consisted of participants who were treated with icatibant and had sufficient icatibant plasma concentration time measurements to derive primary PK parameters. Here the number of participants analyzed signifies participants who were evaluable for this measure. | h | MEAN |
| PRIMARY | Number of Participants With Clinically Significant Changes in Vital Signs | Pre-dose up to 97 days post-dose | Safety population consisted of participants who were treated with icatibant at least once during the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs) | 6 - 8 hours post-dose on Day 1 | Safety population consisted of participants who were treated with icatibant at least once during the study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group144
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant | Prepubertal | 0.42 | Standard Deviation 0.13 | Hour (h) | |
| Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant | Pubertal/Postpubertal: With Acute Attack | 0.55 | Standard Deviation 0.19 | Hour (h) | |
| Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant | Pubertal/Postpubertal: Without Acute Attack | 0.57 | Standard Deviation 0.17 | Hour (h) | |
| Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant | Prepubertal | 659 | Standard Deviation 158 | Nanogram per milliliter (ng/mL) | |
| Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant | Pubertal/Postpubertal: With Acute Attack | 805 | Standard Deviation 125 | Nanogram per milliliter (ng/mL) | |
| Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant | Pubertal/Postpubertal: Without Acute Attack | 761 | Standard Deviation 133 | Nanogram per milliliter (ng/mL) | |
| Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant | Prepubertal | 10.8 | Standard Deviation 4.63 | Milliliters per minute (mL/min) | |
| Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant | Pubertal/Postpubertal: With Acute Attack | 13.1 | Standard Deviation 3.42 | Milliliters per minute (mL/min) | |
| Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant | Pubertal/Postpubertal: Without Acute Attack | 19.3 | Standard Deviation 4.84 | Milliliters per minute (mL/min) | |
| Area Under the Plasma Concentration-time Curve From Time Zero to 4 Hours Post-dose (AUC0-4) of a Single Subcutaneous (SC) Dose of Icatibant | Prepubertal | 1241 | Standard Deviation 319 | Hour*nanogram per milliliter (h*ng/mL) |
1 to 10 of 144Source ClinicalTrials.gov
See all 144 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Initial Icatibant Exposure | STARTED | Prepubertal | 11 | |
| Initial Icatibant Exposure | STARTED | Pubertal/Postpubertal | 21 | |
| Initial Icatibant Exposure | COMPLETED | Prepubertal | 11 | |
| Initial Icatibant Exposure | COMPLETED | Pubertal/Postpubertal | 9 | |
| Initial Icatibant Exposure | NOT COMPLETED | Prepubertal | 0 | |
| Initial Icatibant Exposure | NOT COMPLETED | Pubertal/Postpubertal | 12 | |
| Icatibant Exposure 2 | STARTED | Prepubertal | 0 | |
| Icatibant Exposure 2 | STARTED | Pubertal/Postpubertal | 9 | |
| Icatibant Exposure 2 | COMPLETED | Prepubertal | 0 | |
| Icatibant Exposure 2 | COMPLETED | Pubertal/Postpubertal | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events45
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 | Anaemia | Blood and lymphatic system disorders | Prepubertal | 1 | 11 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Pubertal/Post-pubertal | 0 | 21 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Overall | 1 | 32 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Prepubertal | 1 | 11 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Pubertal/Post-pubertal | 0 | 21 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Overall | 1 | 32 | 1 |
| other | Conjunctivitis | Eye disorders | Prepubertal | 0 | 11 | 0 |
| other | Conjunctivitis | Eye disorders | Pubertal/Post-pubertal | 2 | 21 | 5 |
| other | Conjunctivitis | Eye disorders | Overall | 2 | 32 | 5 |
| other | Conjunctivitis allergic | Eye disorders | Prepubertal | 0 | 11 | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Prepubertal | 0 | 11 |
| Total, all-cause mortality | Pubertal/Post-pubertal | 0 | 21 |
| Total, all-cause mortality | Overall | 0 | 32 |
| Total, other adverse events | Prepubertal | 4 | 11 |
| Total, other adverse events | Pubertal/Post-pubertal | 8 | 21 |
| Total, other adverse events | Overall | 12 | 32 |
| Total, serious adverse events | Prepubertal | 0 | 11 |
| Total, serious adverse events | Pubertal/Post-pubertal | 0 | 21 |
| Total, serious adverse events | Overall | 0 | 32 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 28601641 | 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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Prepubertal vs Pubertal/Postpubertal: Number of Participants With Adverse Events (AEs) | Trial comparisons |
| Prepubertal vs Pubertal/Postpubertal: Number of Participants With Clinically Significant Changes in Clinical Laboratory Evaluations | Trial comparisons |
| Prepubertal vs Pubertal/Postpubertal: Number of Participants With Clinically Significant Changes in Reproductive Hormones | Trial comparisons |
| Prepubertal vs Pubertal/Postpubertal: Number of Participants With Clinically Significant Changes in Vital Signs | Trial comparisons |
| Prepubertal vs Pubertal/Postpubertal: Number of Participants Who Reported Presence of Anti-icatibant Antibodies | Trial comparisons |
| Prepubertal vs Pubertal/Postpubertal: Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs) | 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/NCT01386658
GET https://conductscience.org/api/trials/v1/NCT01386658/registered?page=2