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Long-term Safety and Efficacy Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE

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Disease Information

Descriptive Information
Brief Title † Long-term Safety and Efficacy Study of DX-2930 to Prevent Acute Angioedema Attacks in Patients With Type I and Type II HAE
Official Title † HELP Study ExtensionTM: An Open-Label Study to Evaluate the Long-Term Safety and Efficacy of DX-2930 for Prevention Against Acute Attacks of Hereditary Angioedema (HAE)
Brief Summary This study is an open-label, long term safety and efficacy study to evaluate DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.
Detailed Description
Study Phase Phase 3
Study Type † Interventional
Study Design †
Primary Outcome Measure † Evaluate the long-term safety of repeated subcutaneous (SC) administrations of DX-2930 through analyses based on treatment-emergent Adverse Events (AEs)
Secondary Outcome Measure † Evaluate the long-term efficacy of DX-2930 in preventing HAE attacks in accordance with the HAE Attack Assessment and Reporting Procedures (HAARP).
Condition † Hereditary Angioedema
Intervention † DrugDX-2930
Study Arms / Comparison Groups Rollover Subjects who rollover from the DX-2930-03 study Non-rollover Subjects who were not participants in DX-2930-03
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 † Drug
Estimated Enrollment † 220
Start Date † September 2016
Completion Date February 2018
Primary Completion Date February 2018
Eligibility Criteria † Inclusion Criteria: - Male and female HAE subjects who are 12 years of age or older at the time of screening - Documented diagnosis of HAE, Type I or II - A historical baseline HAE attack rate of at least 1 attack per 12 weeks - Adult subjects and caregivers of subjects under the age of 18 are willing and able to read, understand, and sign an informed consent form. Subjects age 12 to 17, whose caregiver has provided informed consent, are willing and able to read, understand and sign an assent form. - Males and females who are fertile and sexually active must adhere to contraception requirements for the duration of the study Exclusion Criteria: - Discontinued from DX-2930-03 after enrollment for any reason. - If rolling over from DX-2930-03, presence of important safety concerns that would preclude participation in this study. - Concomitant diagnosis of another form of chronic, recurrent angioedema, such as acquired angioedema (AAE), HAE with normal C1-INH (also known as HAE Type III), idiopathic angioedema, or recurrent angioedema associated with urticaria. - Dosing with an investigational drug (not including DX-2930 or other HAE therapies) or exposure to an investigational device within 4 weeks prior to screening. - Exposure to angiotensin-converting enzyme (ACE) inhibitors within 4 weeks prior to screening or any newly initiated or dose modification of estrogen-containing medications with systemic absorption (such as oral contraceptives or hormonal replacement therapy) 3 months prior to the screening visit. - Unwilling to discontinue use of long-term prophylactic therapy for HAE (C1-INH, attenuated androgens, or anti-fibrinolytics) within 3 weeks after starting DX-2930 treatment. - Any of the following liver function test abnormalities: alanine aminotransferase (ALT) > 3x upper limit of normal, or aspartate aminotransferase (AST) > 3x upper limit of normal, or total bilirubin > 2x upper limit of normal (unless the bilirubin elevation is a result of Gilbert's Syndrome). - Pregnancy or breastfeeding.
Gender All
Ages 12 Years - N/A
Accepts Healthy Volunteers No
Contacts ††
Location Countries † Canada
Administrative Information
NCT ID † NCT02741596
Organization ID DX-2930-04
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Shire
Collaborators ††
Investigators † Study Director: Shire Physician, Shire
Information Provided By
Verification Date March 2017
First Received Date † April 8, 2016
Last Updated Date March 13, 2017
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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