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Completed

NCT Number: NCT00500656

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

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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Key information

Conditions

Hereditary Angioedema Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Università degli Studi di Milano, Dipartimento di Medicina Interna

Milan, 20123, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Icatibant

Drug

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

Other names: Brand name, Firazyr®

Tranexamic Acid

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.

oral placebo

Drug

hard capsule matched to tranexamic acid

Other names: Placebo

S.C. Placebo

Drug

solution for injection, matched to icatibant for injection

Other names: Placebo

Primary outcomes

  1. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study title

Randomised Double Blind, Controlled, Parallel Group, Multicentre Study of a Subcutaneous Formulation of Icatibant Versus Oral Tranexamic Acid for the Treatment of Hereditary Angioedema (HAE)

Acronym: FAST2

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Jul 13, 2007
Registry last updated
Jun 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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