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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-01

Study Completion Date

2006-07-25

Brief Summary

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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

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Detailed Description

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This was a Phase III, randomised, double blind, double dummy, multicentre, controlled,parallel group study of a 30 mg s.c. formulation of icatibant for the treatment of patients with moderate to very severe symptoms of cutaneous and/or abdominal symptoms of HAE.

The study consisted of two parts: controlled phase and OLE phase. For the primary endpoint, Efficacy was determined by evaluating the differences in study outcomes using a Visual Analogue Scale for patients treated with icatibant and tranexamic acid.

Conditions

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Hereditary Angioedema

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Randomized controlled -Icatibant

Subjects received S.C icatibant+ oral placebo

Icatibant Form: solution for injection, 3 mL, 10 mg/mL Single dose: 30 mg (3 mL)

Placebo Form: hard capsule Single dose: 2 capsules Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart

Group Type EXPERIMENTAL

Icatibant

Intervention Type DRUG

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

Oral Placebo

Intervention Type DRUG

hard capsule matched to tranexamic acid

Randomized controlled-Tranexamic acid

Subjects received oral Tranexamic acid+ S.C. placebo

Tranexamic acid Form: over encapsulated film tablet Single dose: 1000 mg (2 capsules) Frequency: 3 x 2 capsules for 2 days, taken orally, 6 to 8 hours apart

Placebo Form: solution for injection, matched to icatibant for injection Single dose: 3 mL Frequency: one subcutaneous injection in the abdominal region

Group Type ACTIVE_COMPARATOR

Tranexamic Acid

Intervention Type DRUG

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.

S.C. Placebo

Intervention Type DRUG

solution for injection, matched to icatibant for injection

Controlled Open-label / laryngeal attack

Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.

Group Type EXPERIMENTAL

Icatibant

Intervention Type DRUG

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

Untreated patients at the baseline

Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant

Group Type EXPERIMENTAL

Icatibant

Intervention Type DRUG

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

Interventions

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Icatibant

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

Intervention Type 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.

Intervention Type DRUG

Oral Placebo

hard capsule matched to tranexamic acid

Intervention Type DRUG

S.C. Placebo

solution for injection, matched to icatibant for injection

Intervention Type DRUG

Other Intervention Names

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Brand name, Firazyr® Placebo Placebo

Eligibility Criteria

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Inclusion Criteria

* Age above 18 years;
* Documented diagnosis of HAE Type I or II (confirmed C1-INH deficiency);
* Current edema in the cutaneous, abdominal and/or laryngeal areas;
* Current edema moderate to severe according to the investigator's Symptom Score.

Exclusion Criteria

* Diagnosis of angioedema other than HAE,
* Participation in a clinical trial of another investigational medicinal product (IMP)within the past month
* Treatment with any pain medication since onset of the current angioedema attack
* Treatment with replacement therapy, including C1-INH products, less than 3 days before onset of the current angioedema attack
* Treatment with Tranexamic acid replacement therapy within a week before onset of the current angioedema attack
* Treatment with ACE inhibitors
* Contraindications for Tranexamic acid
* Evidence of coronary artery disease based on medical history or Screening examination in particular unstable angina pectoris or severe coronary heart disease
* Congestive heart failure (class 3 and 4)
* Serum creatinine level of ≥ 250 μmol/L
* Serious concomitant illness that the investigator considered to be a contraindication for participation in the trial
* Pregnancy (as assessed prior to treatment) and/or breast-feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No