CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 8 enrolled
Drug / intervention
Icatibantdrug
Likely dose
Icatibant 30 mg SC injection in the abdominal areaAI-extracted
Key inclusion· 6
  • ✓Confirmed diagnosis of HAE type I or II based on C1-INH deficiency (quantitative and/or functional)
  • ✓HAE attack in cutaneous, abdominal, and/or laryngeal areas
  • ✓Attack severity: moderate-to-severe for non-laryngeal; mild-to-moderate for laryngeal
  • ✓Treatment initiated within 6-12 hours of attack onset
Key exclusion· 10
  • ✕Diagnosis of angioedema other than HAE (e.g., acquired angioedema)
  • ✕Previous treatment with icatibant
  • ✕Enrolled in another clinical study with investigational product within 30 days
  • ✕Pain medication received since attack onset

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03888755
NCT03888755Phase 3Completed
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An Open-Label Study of Icatibant in Japanese Subjects With Acute Attacks of Hereditary Angioedema.

Shire·interventional·Posted Mar 25, 2019·Updated Jun 3, 2021

In Brief

A Phase 3 clinical trial evaluating Icatibant for Hereditary Angioedema (HAE). Completed, enrolled 8 participants across 8 sites.

Detailed Summary

The objective of this study is to evaluate the efficacy, pharmacokinetics (PK), and safety of icatibant for the treatment of acute attacks in Japanese participants with type I or type II hereditary angioedema (HAE).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHereditary Angioedema (HAE)
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 25, 2019
Enrollment StartMar 18, 2015
Primary CompletionFeb 12, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.3 years ago

Interventions

Icatibantdrug

Participants will receive icatibant 30 mg SC injection in the abdominal area.