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Hereditary Angioedema / HAE Trials

Clinical Research Associates of Tidewater located in Norfolk,
Virginia is conducting two clinical trials for individuals with
Hereditary Angioedema (HAE).
Clinical Research Associates of Tidewater has been conducting phase
II – IV clinical trials since 1983. The Medical Director, Dr. Duane
Wombolt, is board certified in internal medicine. Conveniently
located in the Norfolk Medical Tower, Clinical Research Associates
of Tidewater is accessible to all cities and outlying counties in
the Hampton Roads area.
Individuals participating in Hereditary Angioedema / HAE trials live
in Richmond, Williamsburg, Newport News, Hampton, Suffolk, Norfolk,
Portsmouth, Chesapeake, Virginia Beach, the Eastern Shore of
Virginia as well as Northeastern North Carolina.
Hereditary Angioedema (HAE)
Background
Hereditary Angioedema (HAE) is a rare inherited disorder
characterized by recurrent and self-limiting episodes of edema
(swelling) of the skin, larynx (voice box), and gastrointestinal
tract. There are two separate types of HAE (Type I and Type II).
Depending on type, individuals have either mutant forms or low
functional serum (blood) concentration of C1 esterase inhibitor
(C1-INH). Frequency of attacks varies among individuals and is not
uniform within families. HAE attacks generally last 1-4 days.
Therapies for HAE in the United States are currently limited.
Medical management of HAE involves treatment of symptoms in acute
attacks and maintenance therapy. Maintenance therapy consists of
treatment with androgens (steroids that acts as a male sex hormone).
However, their use is accompanied by significant side effects and
long term safety has not been assessed.
Additional information about HAE is available at:
www.haea.org
This is what an HAE attack looks like:
Click below to watch the WAVY TV-10 news story about a local family
in Virginia Beach diagnosed with HAE.

Current Hereditary Angioedema (HAE) Clinical Trials
Both clinical trials are designed to treat individuals experiencing
an acute attack of HAE.
Icatibant HAE Trial
Icatibant was developed by Aventis AG and has been licensed to
Jerini AG for the indication of HAE.
Icatibant (Icat) is a potent, selective peptidomimetric antagonist
of the bradykinin beta 2-receptor (inhibits inflammation). Inflammation at the cell
level contributes to acute attacks of HAE.
To participate in this study one must have either Type I or Type II
HAE, be at least 18 years of age and must be experiencing an acute
attack of HAE.
DX-88 HAE Trial
DX-88 was developed by Dyax-Genzyme LLC. DX-88 is a protein that
inhibits the first stages of inflammation also associated with acute
attacks of HAE.
To participate in this study one must have either Type I or Type II
HAE, be at least 10 years of age, and must be experiencing an acute
attack of HAE.
Financial compensation may be available for time and travel in both
trials and an office screening visit is required prior to acute
treatment.
For More Information and to Contact Us:
Please visit us on the web at
www.crat.org or call us at 757-627-7446.

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