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Trial record 8 of 9 for:    ecallantide | angioedema

EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01826916
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : November 14, 2018
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Brief Summary:
EDEMA2 is an open-label, Phase 2 dose-ranging study designed to assess the safety and efficacy of repeated dosing of DX-88 (recombinant plasma kallikrein inhibitor) in Patients with Hereditary Angioedema.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema (HAE) Drug: DX-88 (ecallantide) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EDEMA2: An Open-Label Study to Assess the Efficacy and Tolerability of Repeated Doses of DX-88 (Recombinant Plasma Kallikrein Inhibitor) in Patients With Hereditary Angioedema
Actual Study Start Date : November 1, 2003
Actual Primary Completion Date : December 1, 2005
Actual Study Completion Date : January 1, 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema
Drug Information available for: Ecallantide

Arm Intervention/treatment
Experimental: 5mg/m2 DX-88 IV
5mg/m2 DX-88 (ecallantide)administered intravenously
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL

Experimental: 10mg/m2 DX-88 IV
10mg/m2 DX-88(ecallantide)administered intravenously
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL

Experimental: 20mg/m2 DX-88 IV
20mg/m2 DX-88 (ecallantide) administered intravenously
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL

Experimental: 30 mg DX-88 SC
30mg DX-88(ecallantide)administered subcutaneously
Drug: DX-88 (ecallantide)
solution for injection 10 mg/mL

Primary Outcome Measures :
  1. Proportion of attacks treated with successful outcome [ Time Frame: 24 hours ]
    successful outcome is defined as attack resolution begun within 4 hrs after treatment and maintained for 24 hours

  2. Proportion of attacks with a partial response [ Time Frame: 24 hours ]
    partial response is defined as an initial response to dosing followed by a relapse within 4 to 24 hours

Secondary Outcome Measures :
  1. Proportion of patients who respond to a 2nd dose of ecallantide after an initial, partial response [ Time Frame: 24 hours ]
  2. Time to resolution onset of each acute attack, as determined by patient report [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 10 years of age or older
  • Documented diagnosis of HAE (Type I or II)
  • Patient reported to a study site no later than 4 hours following patient recognition of the onset of the attack
  • Willing and able to give informed consent

Exclusion Criteria:

  • Patients with a serious intercurrent illness or serious active infection
  • Patient with serum creatinine greater than 110% the upper limit of normal or liver transaminases 2 times the upper limit of normal
  • Receipt of an investigational drug or device, within 30 days prior to study treatment
  • Pregnancy or breastfeeding
  • Diagnosis of acquired angioedema (AAE)
  • Patients who had not completed their Day-7 follow-up procedures for a previously treated attack
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bill Pullman, MD, PhD, Executive Vice President, Chief Development Officer, Dyax Corp. Identifier: NCT01826916    
Other Study ID Numbers: DX-88/5
EDEMA2 ( Other Identifier: Dyax )
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Additional relevant MeSH terms:
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Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Immune System Diseases
Genetic Diseases, Inborn
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents