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

Hereditary Angioedema Clinical Trial

— FAST2  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500656
• Other study ID #: JE049 #2102
• Secondary ID: 2004-001540-71
• Status: Completed
• Phase: Phase 3
• Start date: March 1, 2005
• Est. completion date: July 25, 2006

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: July 25, 2006
• Est. primary completion date: July 25, 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

Drug:
• Icatibant
Icatibant: a stable, synthetic decapeptide and specific BK B2 receptor antagonist.
• 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.
• Oral Placebo
hard capsule matched to tranexamic acid
• S.C. Placebo
solution for injection, matched to icatibant for injection

Locations

Country	Name	City	State
Italy	Università degli Studi di Milano, Dipartimento di Medicina Interna	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

Italy, 

References & Publications (1)

Bas M, Bier H, Greve J, Kojda G, Hoffmann TK. Novel pharmacotherapy of acute hereditary angioedema with bradykinin B2-receptor antagonist icatibant. Allergy. 2006 Dec;61(12):1490-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Onset of Symptom Relief.	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.	2 days
Secondary	Time to Almost Complete Symptom Relief	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.	48 hours