Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE) (FAST2)

This study has been completed.
Sponsor:
Information provided by:
Jerini AG
ClinicalTrials.gov Identifier:
NCT00500656
First received: July 12, 2007
Last updated: June 24, 2008
Last verified: June 2008

July 12, 2007
June 24, 2008
March 2005
Not Provided
Symptom relief (patient)
Same as current
Complete list of historical versions of study NCT00500656 on ClinicalTrials.gov Archive Site
Safety and tolerability Additional efficacy assessments Pharmacoeconomics
Same as current
Not Provided
Not Provided
 
Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema (HAE)
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)

Primary Outcome Measures:

Symptom relief (patient)

Secondary Outcome Measures:

Safety and tolerability Additional efficacy assessments Pharmacoeconomics

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Hereditary Angioedema
Drug: IMP: Icatibant, comparator: Tranexamic acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
March 2008
Not Provided

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT00500656
JE049 #2102
Yes
Not Provided
Jerini AG
Not Provided
Principal Investigator: Marco Cicardi, Prof. Dr. University of Milan
Jerini AG
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP