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Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)

NCT00500656 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2021-06-09

Study results available
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Summary

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

Conditions

Interventions

DRUG

Icatibant

Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist.

DRUG

Tranexamic Acid

over encapsulated film tablet an anti-fibrinolytic agent,is used in some European countries for the treatment of acute oedema episodes and the continuous prophylaxis of HAE.

DRUG

Oral Placebo

hard capsule matched to tranexamic acid

DRUG

S.C. Placebo

solution for injection, matched to icatibant for injection

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-01
Primary Completion
2006-07-25
Completion
2006-07-25

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00500656 on ClinicalTrials.gov