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
  Purpose

Primary Outcome Measures:

Symptom relief (patient)

Secondary Outcome Measures:

Safety and tolerability Additional efficacy assessments Pharmacoeconomics


Condition Intervention Phase
Hereditary Angioedema
Drug: IMP: Icatibant, comparator: Tranexamic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Jerini AG:

Primary Outcome Measures:
  • Symptom relief (patient)

Secondary Outcome Measures:
  • Safety and tolerability Additional efficacy assessments Pharmacoeconomics

Enrollment: 80
Study Start Date: March 2005
Study Completion Date: March 2008
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00500656

Locations
Italy
Università degli Studi di Milano, Dipartimento di Medicina Interna
Milano, Italy, 20123
Sponsors and Collaborators
Jerini AG
Investigators
Principal Investigator: Marco Cicardi, Prof. Dr. University of Milan
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00500656     History of Changes
Other Study ID Numbers: JE049 #2102
Study First Received: July 12, 2007
Last Updated: June 24, 2008
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Tranexamic Acid
Icatibant
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Adrenergic beta-Antagonists

ClinicalTrials.gov processed this record on April 23, 2014