Current partner codePEPTIDESDE
NCT00500656·Phase 3·INTERVENTIONAL

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

Status

Completed

Phase

Phase 3

Enrollment

85

Locations

1

Results

Posted

Publications

3

Study summary

What the protocol is testing.

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

Full detailed description

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.

Interventions

Treatment arms and agents.

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

Timeline

From registration to results.

  1. First posted

    Jul 13, 2007

  2. Study start

    Mar 1, 2005

  3. Primary completion

    Jul 25, 2006

  4. Study completion

    Jul 25, 2006

  5. Results posted

    Jun 9, 2014

  6. Registry updated

    Jun 9, 2021

Outcomes

What the study measures.

Primary outcomes

Time to Onset of Symptom Relief.

Time frame · 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 abdominal pain. For cutaneous attacks, the single primary symptom was either skin swelling or skin pain, whichever was most severe.

Secondary outcomes

Time to Almost Complete Symptom Relief

Time frame · 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.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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

Study locations

1 registered sites.

Italy. Showing up to 24 locations stored in the fast local snapshot.

Università degli Studi di Milano, Dipartimento di Medicina Interna

Milan, Italy

Publications

Results and literature.

Primary links

Continue at the source.

Related trials

More studies on Icatibant.

Related PeptideStat pages

Put the record in context.

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