Hereditary Angioedema
Conditions
Interventions
Product Name: DX-88 (ecallantide)
Product Code: DX-88
Pharmaceutical Form: Solution for injection
INN or Proposed INN: ecallantide
Current Sponsor code: DX-88
Concentration unit: mg/ml milligram(s)/mi
Sponsors
Dyax Corp
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Age 10 years or older 2.Documented diagnosis of HAE, Type I or II Diagnosis must meet the following criteria: •Documented clinical history consistent with HAE, •Documented reduction of either functional or antigenic C1-INH (below the lower limit of normal as defined by the laboratory performing the test), •Documented reduction of C4 (below the lower limit of normal as defined by the laboratory performing the test), and •Age of reported onset of first symptoms = 25 years OR documented C1q level at or above the lower limit of normal (as defined by the laboratory performing the test) 3.Executed informed consent 4.Enrollment Visit: An acute attack of HAE having at least one symptom complex with a severity assessment of moderate or severe 5.Enrollment Visit: Presentation for treatment at the site within 8 hours of patient recognition of moderate to severe symptoms in an acute attack of HAE Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Receipt of an investigational drug or device, other than DX-88, within 30 days prior to study enrollment 2.Treatment with non-investigational C1-INH within 7 days prior to study enrollment 3.Diagnosis of acquired angioedema ?AAE?, estrogen dependent angioedema and/or drug induced angioedema (including angiotensin-converting enzyme inhibitor induced angioedema) 4.Pregnancy or breast feeding 5.Patients who have received DX-88 (in EDEMA2 or any other studies with DX-88) within 7 days of presentation for dosing in the Double-blind Phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and efficacy of DX-88 in the treatment of acute attacks of Hereditary Angioedema;Secondary Objective: ;Primary end point(s): Treatment Outcome Score (TOS) at 4 hours based on the severity assessment of symptom complex(es) as determined by patient | — |
Countries
Belgium, Italy, United Kingdom
Outcome results
None listed