Clinical Trials

Please Participate in HAE Clinical Trials and Fill Out the HAE Association's Clinical Trial Interest Form

Currently there are four companies conducting clinical trials with the goal of getting their HAE treatments. Rare diseases and small patient populations usually do not receive this much attention, so we must take full advantage of this "once in a lifetime opportunity" for approval of several different HAE therapies. However, nothing will happen unless we make sure each of these trials has sufficient participants. We hope each and every HAE friend will help themselves and other family members by participating.

HAE patients interested in clinical trials can either fill out our Clinical Trial Form, or contact The HAE Association's Clinical Trial Programs Director Donna Davis.

Please note: Any information you provide to the HAE Association is carefully safeguarded to eliminate even the slight possibility of unauthorized disclosure.

Once you have completed the form, Donna Davis or one of her Clinical Associates will contact you with information regarding clinical trial sites in your area. Alternatively, if you have frequent attacks and indicate that you are willing to travel and stay in a hotel near a trial site (travel and lodging expenses will be paid by the trial sponsor), you will be contacted with information regarding how this could be arranged. It is important to note that the HAE Association will work with you, your doctor, and the pharmaceutical company to make sure you have medicine available so you can get treated for attacks that occur after your travel is completed.

Below is some information regarding the companies looking to license their medicines in the United States

• Dyax/ Genzyme
  Dyax is now conducting a phase 3 trial of its subcutaneously administered drug, Ecalantide, which is designed to stop HAE attacks by blocking kallikrein, a protein implicated in the underlying cause of swelling in HAE patients.
• Jerini
  Jerini recently completed both of its Phase III clinical trials of Icatibant, another HAE treatment that is administered subcutaneously. Jerini completed their trial in mid 2006 and plans to submit an application to license Icatibant in the United States
• Lev Pharmaceuticals
  Lev Pharma announced that it completed the acute attack treatment portion of its pivotal Phase III clinical trial. Patients enrolled in this study will continue to receive open label treatment for attacks. The brand of C1- inhibitor concentrate being tested by Lev Pharmaceuticals has been used safely and effectively in the Netherlands for more than 30 years
• Pharming
  Pharming is testing a C1-Inhibitor concentrate product that is derived from genetically altered rabbits that produce human C1-inhibitor in their milk.
• ZLB-Behring
  ZLB Behring is conducting a Phase III clinical trial of their C1-Inhibitor concentrate product, Berinert-P. which also has an impeccable decades-long record of safely and effectively treating HAE patients in Europe and other parts of the world.

Click here for more information on the ongoing clinical trials for HAE.