18 and older, any sex, with Hereditary Angioedema. 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 Onset of Symptom Relief.Primary· 2 days
The primary efficacy endpoint was Time to onset of symptom relief (TOSR) following treatment with either icatibant or tranexamic acid. The median time to onset of symptom relief for the icatibant group was compared to the the median time to onset of symptom relief for the tranexamic acid group. TOSR was defined as the time between time of injection to time of first documented onset of symptom relief for the three primary symptoms: cutaneous swelling, cutaneous skin, and abdominal pain. The primary symptom was based on the type of attack. For abdominal attacks, the single primary symptom was ab
Group
Value
95% CI
Randomized Controlled -Icatibant
2.0
1.0 – 3.5
Randomized Controlled-Tranexamic Acid
12.0
3.5 – 25.4
Time to Almost Complete Symptom ReliefSecondary· 48 hours
Almost complete symptom relief was defined as a score between 0 and 10 mm on the VAS for at least three consecutive measurements for all symptoms.
Group
Value
95% CI
Randomized Controlled -Icatibant
10.0
2.8 – 23.2
Randomized Controlled-Tranexamic Acid
51.0
12.0 – 79.5
Adverse events — posted to ClinicalTrials.gov
Time frame: An AE was assigned to the controlled phase if the start date of the event was between the first treatment of the first attack and the first treatment in the OLE phase..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Primary Outcome Measures:
The primary endpoint was the time to onset of symptom relief of the first attack in the double blind phase. H0: λ icatibant/λ tranexamic acid =1 versus H1: λ icatibant/λ tranexamic acid ≠1 Where: λ icatibant refers to the hazard rate under icatibant and λ tranexamic acid refers to the hazard rate under tranexamic acid.
Secondary Outcome Measures:
* Additional efficacy assessments (Time to Almost Complete Symptom Relief)
* Safety and tolerability
* Pharmacoeconomics
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06960213 — STOP-HAE: A Phase 3 Study of ADX-324 in HAE
· Phase 3
· recruiting
NCT06806657 — Safety Study in Subjects ≥ 12 Years of Age With Hereditary Angioedema Switching to Garadacimab
· Phase 4
· recruiting
NCT06573723 — Institutional Registry of Rare Diseases
· recruiting
NCT05691361 — Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients
· Phase 1, PHASE2
· active not recruiting
NCT05505916 — An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angio
· Phase 3
· active not recruiting
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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: 9 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/NCT00500656.