Efficacy and Safety Study of DX-88 to Treat Acute Attacks of Hereditary Angioedema (HAE)
NCT ID: NCT00262080
Last Updated: 2021-06-11
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
91 participants
INTERVENTIONAL
2005-12-31
2007-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)
NCT00456508
Efficacy Study of DX-88 (Ecallantide) to Treat Acute Attacks of Hereditary Angioedema (HAE)
NCT00457015
EDEMA2: Evaluation of DX-88's Effect in Mitigating Angioedema
NCT01826916
Efficacy and Safety Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
NCT02586805
Oral Deucrictibant for Prophylactic and Acute Treatment in Hereditary Angioedema Patients
NCT07046806
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
DX-88 (ecallantide)
DX-88 (ecallantide) 30 mg given as three 10 mg/mL subcutaneous injections.
ecallantide
dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
Placebo
Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
Phosphate Buffer Saline (PBS),
given as three 1mL subcutaneous injections.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ecallantide
dose of 30 mg (10 mg/ml) given as 3 subcutaneous injections.
Phosphate Buffer Saline (PBS),
given as three 1mL subcutaneous injections.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Documented diagnosis of HAE, Type I or II
* Executed informed consent
* Presentation for treatment within 8 hours of patient recognition of moderate to severe HAE attack
Exclusion Criteria
* Receipt of non-investigational C1-INH (C1 esterase inhibitor) within 7 days of treatment
* Diagnostic of acquired angioedema, estrogen-dependent angioedema or drug induced angioedema
* Pregnancy or breastfeeding
* Patients who have received DX-88 within 7 days of presentation for dosing in the Double-blind Phase
10 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shire
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institute for Asthma and Allergy
Wheaton, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Sheffer AL, MacGinnitie AJ, Campion M, Stolz LE, Pullman WE. Outcomes after ecallantide treatment of laryngeal hereditary angioedema attacks. Ann Allergy Asthma Immunol. 2013 Mar;110(3):184-188.e2. doi: 10.1016/j.anai.2012.12.007. Epub 2013 Jan 5.
Bernstein JA, Shea EP, Koester J, Iarrobino R, Pullman WE. Assessment of rebound and relapse following ecallantide treatment for acute attacks of hereditary angioedema. Allergy. 2012 Sep;67(9):1173-80. doi: 10.1111/j.1398-9995.2012.02864.x. Epub 2012 Jul 5.
Riedl M, Campion M, Horn PT, Pullman WE. Response time for ecallantide treatment of acute hereditary angioedema attacks. Ann Allergy Asthma Immunol. 2010 Dec;105(6):430-436.e2. doi: 10.1016/j.anai.2010.09.005. Epub 2010 Oct 25.
Cicardi M, Levy RJ, McNeil DL, Li HH, Sheffer AL, Campion M, Horn PT, Pullman WE. Ecallantide for the treatment of acute attacks in hereditary angioedema. N Engl J Med. 2010 Aug 5;363(6):523-31. doi: 10.1056/NEJMoa0905079.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EDEMA3 (DX-88/14)
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.