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Randomized, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Angioedema

Thank you

Trial Information

Randomized, Double Blind, Placebo-Controlled, Multicenter Study of a Subcutaneous Formulation of Icatibant for the Treatment of Hereditary Angioedema


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Outcome Measure:

Symptom relief (patient)

Authority:

United States: Food and Drug Administration

Study ID:

JE049 #2103

NCT ID:

NCT00097695

Start Date:

August 2004

Completion Date:

March 2008

Related Keywords:

  • Angioedema
  • Hereditary Angioedema
  • C1 inhibitor deficiency
  • HAE
  • Icatibant
  • Bradykinin antagonist
  • acute attack
  • subcutaneous
  • Angioedema
  • Angioedemas, Hereditary

Name

Location

Georgetown University Hospital, Lombardi Cancer CenterWashington, District of Columbia  20007-2197