NCT01386658 is a Phase 3 clinical trial of icatibant in Hereditary Angioedema (HAE), sponsored by Shire.

Who is sponsoring NCT01386658?

NCT01386658 is sponsored by Shire.

What drugs are being tested in NCT01386658?

Interventions in NCT01386658: icatibant.

What condition does NCT01386658 study?

NCT01386658 studies Hereditary Angioedema (HAE).

Is NCT01386658 still recruiting?

NCT01386658 is currently completed. Last updated 8 June 2021.

Are results published for NCT01386658?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-08 · How we verify

NCT01386658

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Pharmacokinetic, Tolerability and Safety Study of Icatibant in Children and Adolescents With Hereditary Angioedema

Completed Phase 3 Results posted Last updated 8 June 2021

What this trial tests

Phase 3 trial testing icatibant in Hereditary Angioedema (HAE) in 32 participants. Completed in 12 March 2018.

Timeline

27 January 2012

Primary endpoint
12 March 2018

12 March 2018

Quick facts

Lead sponsor	Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	27 January 2012
Primary completion	12 March 2018
Estimated completion	12 March 2018
Sites	26 locations across Italy, Colombia, Austria, Germany, Hungary, Israel, Canada, Australia

Drugs / interventions tested

icatibant (ICATIBANT) — full drug profile →

Conditions studied

Hereditary Angioedema (HAE) — all drugs for Hereditary Angioedema (HAE) →

Sponsor

Shire — full company profile →

Who can join

Adults 2 to 17, any sex, with Hereditary Angioedema (HAE). Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Peak Concentration (Tmax) of a Single Subcutaneous (SC) Dose of Icatibant Primary · 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.

Group	Value	95% CI
Prepubertal	0.42	± 0.13
Pubertal/Postpubertal: With Acute Attack	0.55	± 0.19
Pubertal/Postpubertal: Without Acute Attack	0.57	± 0.17

Maximum Plasma Concentration (Cmax) of a Single Subcutaneous (SC) Dose of Icatibant Primary · 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.

Group	Value	95% CI
Prepubertal	659	± 158
Pubertal/Postpubertal: With Acute Attack	805	± 125
Pubertal/Postpubertal: Without Acute Attack	761	± 133

Total Plasma Clearance (CL/F) of a Single Subcutaneous (SC) Dose of Icatibant Primary · 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.

Group	Value	95% CI
Prepubertal	10.8	± 4.63
Pubertal/Postpubertal: With Acute Attack	13.1	± 3.42
Pubertal/Postpubertal: Without Acute Attack	19.3	± 4.84

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 Primary · 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.

Group	Value	95% CI
Prepubertal	1241	± 319
Pubertal/Postpubertal: With Acute Attack	1448	± 304
Pubertal/Postpubertal: Without Acute Attack	1335	± 211

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 Primary · 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.

Group	Value	95% CI
Prepubertal	1289	± 325
Pubertal/Postpubertal: With Acute Attack	1573	± 372
Pubertal/Postpubertal: Without Acute Attack	1398	± 225

Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC0-inf) of a Single Subcutaneous (SC) Dose of Icatibant Primary · 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.

Group	Value	95% CI
Prepubertal	1243	± 244
Pubertal/Postpubertal: With Acute Attack	1710	± 569
Pubertal/Postpubertal: Without Acute Attack	1416	± 229

Volume of Distribution (Vz/F) of a Single Subcutaneous (SC) Dose of Icatibant Primary · 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.

Group	Value	95% CI
Prepubertal	12.5	± 5.28
Pubertal/Postpubertal: With Acute Attack	23.5	± 13.9
Pubertal/Postpubertal: Without Acute Attack	25.4	± 8.87

Elimination Half-life (t1/2) of a Single Subcutaneous (SC) Dose of Icatibant Primary · 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.

Group	Value	95% CI
Prepubertal	0.80	± 0.04
Pubertal/Postpubertal: With Acute Attack	1.34	± 0.96
Pubertal/Postpubertal: Without Acute Attack	0.90	± 0.10

Number of Participants With Clinically Significant Changes in Vital Signs Primary · 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.

Group	Value	95% CI
Prepubertal	0
Pubertal/Postpubertal	0

Number of Participants With Clinically Significant Changes in Electrocardiograms (ECGs) Primary · 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.

Group	Value	95% CI
Prepubertal	0
Pubertal/Postpubertal	0

Number of Participants With Clinically Significant Changes in Clinical Laboratory Evaluations Primary · Pre-dose up to 97 days post-dose

Clinical laboratory evaluations included clinical chemistry (including liver function tests), hematology, urinalysis. The number of participants who reported clinically significant changes in clinical laboratory evaluations were reported.

Group	Value	95% CI
Prepubertal	0
Pubertal/Postpubertal	0

Number of Participants Who Reported Presence of Anti-icatibant Antibodies Primary · Pre-dose up to 97 days post-dose

The number of participants who reported anti-icatibant antibodies were reported.

Group	Value	95% CI
Prepubertal	0
Pubertal/Postpubertal	0

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of study drug administration up to 187 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Prepubertal

Serious: 0/11 (0%)

Deaths: 0/11

Pubertal/Post-pubertal

Serious: 0/21 (0%)

Deaths: 0/21

Overall

Serious: 0/32 (0%)

Deaths: 0/32

Other adverse events (15 terms — click to expand)

Reaction	System	Prepubertal	Pubertal/Post-pubertal	Overall
Nasopharyngitis	Infections and infestations	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—
Conjunctivitis	Eye disorders	—	—	—
Conjunctivitis allergic	Eye disorders	—	—	—
Toothache	Gastrointestinal disorders	—	—	—
Pyrexia	General disorders	—	—	—
Headache	Nervous system disorders	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—
Epiphyseal fracture	Injury, poisoning and procedural complications	—	—	—
Thermal burn	Injury, poisoning and procedural complications	—	—	—
Nitrite urine present	Investigations	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—
Bronchospasm	Respiratory, thoracic and mediastinal disorders	—	—	—

Data from ClinicalTrials.gov NCT01386658 adverse events section.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

Treatment Effect and Safety of Icatibant in Pediatric Patients with Hereditary Angioedema.
Farkas H, Reshef A, Aberer W, Caballero T, et al · · 2017 · cited 37× · PMID 28601641 · DOI 10.1016/j.jaip.2017.04.010
Emerging Therapies in Hereditary Angioedema.
Chen M, Riedl MA. · · 2017 · cited 21× · PMID 28687111 · DOI 10.1016/j.iac.2017.03.003
An evidence-based review of the potential role of icatibant in the treatment of acute attacks in hereditary angioedema type I and II.
Floccard B, Hautin E, Bouillet L, Coppere B, et al · · 2012 · cited 10× · PMID 23055948 · DOI 10.2147/ce.s24743
Pediatric hereditary angioedema: an update.
Sabharwal G, Craig T. · · 2017 · cited 7× · PMID 28781749 · DOI 10.12688/f1000research.11320.1
Continued icatibant use across recurrent attacks in adolescents with hereditary angioedema.
Farkas H, Reshef A, Caballero T, Ortega López MC, et al · · 2021 · PMID 33851451 · DOI 10.1111/pai.13519

Verify or expand the search:

Other recruiting trials for Hereditary Angioedema (HAE)

Currently open trials in the same condition.

NCT07251933 — A Study of Lanadelumab in Children With Hereditary Angioedema (HAE) in Multiple Countries · recruiting
NCT07046806 — Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients · Phase 1, PHASE2 · recruiting
NCT06806618 — HAE Burden and Crisis Management · recruiting
NCT06846398 — A Phase 2 in Adult Subjects With Hereditary Angioedema · Phase 2 · active not recruiting
NCT05469789 — A Study of Lanadelumab in Teenagers and Adults With Hereditary Angioedema (HAE) · active not recruiting

Other Shire trials

Trials by the same sponsor.

NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01386658 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 8 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01386658.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing