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Completed

NCT Number: NCT01826916

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

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.

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Key information

Conditions

Hereditary Angioedema (HAE) Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DX-88 (ecallantide)

Drug

solution for injection 10 mg/mL

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2005
Study completion
2006
First posted
Apr 9, 2013
Registry last updated
May 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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