EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema
NCT ID: NCT01826916
Last Updated: 2021-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
77 participants
INTERVENTIONAL
2003-11-01
2006-01-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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5mg/m2 DX-88 IV
5mg/m2 DX-88 (ecallantide)administered intravenously
DX-88 (ecallantide)
solution for injection 10 mg/mL
10mg/m2 DX-88 IV
10mg/m2 DX-88(ecallantide)administered intravenously
DX-88 (ecallantide)
solution for injection 10 mg/mL
20mg/m2 DX-88 IV
20mg/m2 DX-88 (ecallantide) administered intravenously
DX-88 (ecallantide)
solution for injection 10 mg/mL
30 mg DX-88 SC
30mg DX-88(ecallantide)administered subcutaneously
DX-88 (ecallantide)
solution for injection 10 mg/mL
Interventions
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DX-88 (ecallantide)
solution for injection 10 mg/mL
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
10 Years
ALL
No
Sponsors
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Shire
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
References
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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.
Other Identifiers
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EDEMA2
Identifier Type: OTHER
Identifier Source: secondary_id
DX-88/5
Identifier Type: -
Identifier Source: org_study_id
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