Subcutaneous Treatment With Icatibant for Acute Attacks of Hereditary Angioedema - Full Text View

Sponsor:	Jerini AG
Information provided by:	Jerini AG
ClinicalTrials.gov Identifier:	NCT00097695

Purpose

The purpose of this study is to assess the efficacy and safety of Icatibant, a bradykinin antagonist in the treatment of acute cutaneous and/or abdominal attacks in patients with hereditary angioedema (HAE).

Condition	Intervention	Phase
Angioedema	Drug: Icatibant	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Randomized, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema

Resource links provided by NLM:

Genetics Home Reference related topics: hereditary angioedema Help Me Understand Genetics

Drug Information available for: Icatibant Icatibant acetate

U.S. FDA Resources

Further study details as provided by Jerini AG:

Primary Outcome Measures:

Symptom relief (patient)

Secondary Outcome Measures:

Safety and tolerability
Additional efficacy assessments
Pharmacoeconomics

Estimated Enrollment:	56
Study Start Date:	August 2004
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

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 be in the cutaneous, abdominal and/or laryngeal areas;
Current edema be moderate to severe according to the investigator's Symptom Score.

Exclusion Criteria:

Diagnosis of angioedema other than HAE, for example, acquired angioedema (AAE);
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 edema attack;
Treatment with replacement therapy, including C1-INH products, less than 3 days from onset of the current edema attack;
Treatment with ACE inhibitors;
Evidence of severe, symptomatic coronary artery disease based on medical history or screening examination;
Serious concomitant illnesses that the physician considers to be a contraindication for participation in the trial;
Pregnancy and/or breast-feeding.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00097695

Locations

United States, District of Columbia
Georgetown University Hospital, Lombardi Cancer Center
Washington, District of Columbia, United States, 20007-2197

Sponsors and Collaborators

Jerini AG

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by Jerini AG

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Cicardi M, Banerji A, Bracho F, Malbrán A, Rosenkranz B, Riedl M, Bork K, Lumry W, Aberer W, Bier H, Bas M, Greve J, Hoffmann TK, Farkas H, Reshef A, Ritchie B, Yang W, Grabbe J, Kivity S, Kreuz W, Levy RJ, Luger T, Obtulowicz K, Schmid-Grendelmeier P, Bull C, Sitkauskiene B, Smith WB, Toubi E, Werner S, Anné S, Björkander J, Bouillet L, Cillari E, Hurewitz D, Jacobson KW, Katelaris CH, Maurer M, Merk H, Bernstein JA, Feighery C, Floccard B, Gleich G, Hébert J, Kaatz M, Keith P, Kirkpatrick CH, Langton D, Martin L, Pichler C, Resnick D, Wombolt D, Fernández Romero DS, Zanichelli A, Arcoleo F, Knolle J, Kravec I, Dong L, Zimmermann J, Rosen K, Fan WT. Icatibant, a new bradykinin-receptor antagonist, in hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):532-41.

ClinicalTrials.gov Identifier:	NCT00097695 History of Changes
Other Study ID Numbers:	JE049 #2103, FAST1
Study First Received:	November 26, 2004
Last Updated:	June 24, 2008
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Jerini AG:

Hereditary Angioedema
C1 inhibitor deficiency
HAE
Icatibant

Bradykinin antagonist
acute attack
subcutaneous

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
Icatibant
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic

Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 09, 2012