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Trial record 8 of 9 for:    ecallantide | angioedema

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

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ClinicalTrials.gov Identifier: NCT01826916
Recruitment Status : Completed
First Posted : April 9, 2013
Last Update Posted : November 14, 2018
Sponsor:
Information provided by:
Shire

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
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bill Pullman, MD, PhD, Executive Vice President, Chief Development Officer, Dyax Corp.
ClinicalTrials.gov Identifier: NCT01826916     History of Changes
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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Angioedema
Angioedemas, Hereditary
Ecallantide
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
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