Phase 3
Completed N=32
A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema
Hereditary Angioedema (HAE)
Source: ClinicalTrials.gov NCT01386658 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant — 0.42; 0.55; 0.57 Hour (h)
◆ Published Evidence
Established
56citations · ~6 / year
Treatment Effect and Safety of Icatibant in Pediatric Patients with Hereditary Angioedema.
Summary
HGT-FIR-086 is a multicenter, open-label, non-randomized, single-arm study to evaluate the Pharmacokinetics, tolerability,safety, and efficacy on reproductive hormones, of a single subcutaneous (SC) administration of icatibant in approximately 30 pediatric subjects with Hereditary Angioedema (HAE) during an initial acute attack.
Linked Publications
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Treatment Effect and Safety of Icatibant in Pediatric Patients with Hereditary Angioedema.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant |
0.42; 0.55; 0.57 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant |
659; 805; 761 | — |
| PRIMARY Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant |
10.8; 13.1; 19.3 | — |
| 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 |
1241; 1448; 1335 | — |
| 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 |
1289; 1573; 1398 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of a Single Subcutaneous (SC) Dose of Icatibant |
1243; 1710; 1416 | — |
| PRIMARY Volume of Distribution (Vz/F) of a Single Subcutaneous (SC) Dose of Icatibant |
12.5; 23.5; 25.4 | — |
| PRIMARY Elimination Half-life (t1/2) of a Single Subcutaneous (SC) Dose of Icatibant |
0.80; 1.34; 0.90 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Vital Signs |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs) |
0; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Clinical Laboratory Evaluations |
0; 0 | — |
| PRIMARY Number of Participants Who Reported Presence of Anti-icatibant Antibodies |
0; 0 | — |
| PRIMARY Number of Participants With Adverse Events (AEs) |
2; 11 | — |
| PRIMARY Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 1 |
9; 20; 0; 2 | — |
| PRIMARY Number of Participants Who Reported Injection Site Reactions (ISR) for Icatibant Exposure Number 2 and 3 |
1; 0; 8; 3; 1; 0 | — |
| PRIMARY Number of Participants With Clinically Significant Changes in Reproductive Hormones |
0; 0 | — |
| SECONDARY Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1 |
1.0; 1.0 | — |
| SECONDARY Time to Onset of Symptom Relief (TOSR) for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3 |
4.0; 1.0; 1.0; 1.1 | — |
| SECONDARY Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1 |
0.9; 1.0 | — |
| SECONDARY Time to Onset of Symptom Relief (TOSR) for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3 |
3.0; 1.0; 1.0; 1.1 | — |
| SECONDARY Time to Onset of Symptom Relief (TOSR) for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores |
1.0 | — |
| SECONDARY Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 1 |
1.9; 1.0 | — |
| SECONDARY Time to Minimum Symptoms for Composite Investigator-Assessed Symptom Scores for Icatibant Exposure Number 2 and 3 |
1.2; 2.2 | — |
| SECONDARY Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 1 |
2.4; 3.8 | — |
| SECONDARY Time to Minimum Symptom for Faces Pain Scale-Revised (FPS-R) Scores for Icatibant Exposure Number 2 and 3 |
3.0; 2.1; 5.8; 24.0 | — |
| SECONDARY Time to Minimum Symptom for Faces, Legs, Activity, Cry, and Consolability (FLACC) Scores |
1.0 | — |
| SECONDARY Time to Use of Rescue Medication for the Treatment of Symptoms of the Hereditary Angioedema (HAE) Attack Following Study Drug Administration |
NA; NA | — |
| SECONDARY Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 1 |
0; 1; 0; 0; 0; 0 | — |
| SECONDARY Number of Participants With Worsened Intensity of Clinical Hereditary Angioedema (HAE) Symptoms Between 2 and 4 Hours After Treatment With Icatibant Exposure Number 2 and 3 |
0; 0; 0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Two through <18 years of age at the time of first HAE attack.
- Prepubertal and pubertal/postpubertal subjects experiencing and acute cutaneous, abdominal, or laryngeal HAE attack treated with icatibant as part of this study.
- Pubertal/postpubertal subjects with HAE who are treated with icatibant, but not during an attack.
- Documented diagnosis of HAE Type I or II.
- Informed consent (and subject assent as appropriate) signed by the subject's parent(s)or legal guardian(s).
Exclusion Criteria
- Diagnosis of angioedema other than HAE.
- Participation in another clinical trial that involves the use of any investigational product (drug or device)within 30 days prior to study enrollment or at any time during the study.
- Any known factor/disease that might interfere with the treatment compliance, study conduct,or result interpretation.
- Congenital or acquired cardiac anomalies that interfere significantly with cardiac function.
- Treatment with ACE inhibitors within 7 days prior to treatment.
- Use of hormonal contraception within the 90 days prior to treatment.
- Androgen use (eg, stanozolol, danazol, oxandrolone, methyltestosterone, testosterone) within the 90 days prior to treatment.
- Pregnancy or breastfeeding.
- A physical condition that interferes with pubertal status determination.
Data sourced from ClinicalTrials.gov (NCT01386658) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.