Home
Search
Study Topics
Glossary
|
|
|
|
|
Tracking Information | |||||||||
---|---|---|---|---|---|---|---|---|---|
First Received Date † | April 4, 2007 | ||||||||
Last Updated Date | January 7, 2009 | ||||||||
Start Date † | April 2007 | ||||||||
Current Primary Outcome Measures † |
Change in symptom severity as reported by the patient [ Time Frame: 4 hours ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00456508 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
|
||||||||
Original Secondary Outcome Measures † |
|
||||||||
Descriptive Information | |||||||||
Brief Title † | Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE) | ||||||||
Official Title † | Open-Label Patient Continuation of DX-88 (Ecallantide) for Acute Hereditary Angioedema Attacks | ||||||||
Brief Summary | The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial. |
||||||||
Detailed Description | This is an open label trial. The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study. |
||||||||
Study Phase | |||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
Condition † | Hereditary Angioedema | ||||||||
Intervention † | Drug: ecallantide | ||||||||
Study Arms / Comparison Groups | Experimental: DX-88 (ecallantide) | ||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
Recruitment Information | |||||||||
Recruitment Status † | Recruiting | ||||||||
Estimated Enrollment † | 150 | ||||||||
Estimated Completion Date | December 2009 | ||||||||
Estimated Primary Completion Date | October 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
Gender | Both | ||||||||
Ages | 10 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† |
|
||||||||
Location Countries † | United States, Canada, Jordan | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00456508 | ||||||||
Responsible Party | Bill Pullman, MD, PhD, Executive Vice President, Chief Development Officer, Dyax Corp. | ||||||||
Secondary IDs †† | |||||||||
Study Sponsor † | Dyax Corporation | ||||||||
Collaborators †† | |||||||||
Investigators † |
|
||||||||
Information Provided By | Dyax Corporation | ||||||||
Verification Date | January 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |