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

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

Study Description

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

• 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

Arms and Interventions

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

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

• 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

No Contacts or Locations Provided

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rubinstein E, Stolz LE, Sheffer AL, Stevens C, Bousvaros A. Abdominal attacks and treatment in hereditary angioedema with C1-inhibitor deficiency. BMC Gastroenterol. 2014 Apr 9;14:71. doi: 10.1186/1471-230X-14-71.

MacGinnitie AJ, Davis-Lorton M, Stolz LE, Tachdjian R. Use of ecallantide in pediatric hereditary angioedema. Pediatrics. 2013 Aug;132(2):e490-7. doi: 10.1542/peds.2013-0646. Epub 2013 Jul 22.

• Responsible Party: Bill Pullman, MD, PhD, Executive Vice President, Chief Development Officer, Dyax Corp.
• ClinicalTrials.gov Identifier: NCT01826916
• Other Study ID Numbers: DX-88/5; EDEMA2 ( Other Identifier: Dyax )
• First Posted: April 9, 2013
• Last Update Posted: November 14, 2018
• Last Verified: November 2018

Additional relevant MeSH terms:

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