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Trial record 8 of 9 for:    ecallantide | angioedema
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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.
 
ClinicalTrials.gov Identifier: NCT01826916
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : May 18, 2021
Sponsor:
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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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

Study Design
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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

Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826916


Sponsors and Collaborators
Shire
Investigators
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Study Director: Study Director Takeda
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01826916    
Other Study ID Numbers: DX-88/5
EDEMA2 ( Other Identifier: Dyax )
First Posted: April 9, 2013    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: May 2021
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Ecallantide
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hereditary Complement Deficiency Diseases
 Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents