Hereditary Angioedema (HAE) Clinical Research Studies
Hereditary Angioedema HAE) also known as C1 Esterase Inhibitor Deficiency is a genetic condition that is very rare and can be life threatening. This condition is classified by swelling, or edema in different parts of the body. These can include the hands, feet, face, and airway (throat). Symptoms can also include abdominal pain, nausea, and vomiting. Swelling of the throat is one of the major concerns as this can cause asphyxiation, which can lead to death.
This disease is hereditary, and those with the disease have a 50% chance of passing it on to their children.
Treatment Options for Hereditary Angioedema (HAE)
There are several emergent treatments for HAE. Working in close consultation with the medical experts at our clinics provides patients with various options for treating this complex and rare condition.
Treatment options can include managing acute attacks, prophylaxis, and prophylactic therapy in situations where attacks can occur. Medications can help treat patients who experience abdominal pain. A doctor may perform intubation or tracheostomy in rare cases where respiratory obstruction results from an HAE attack.
FDA-approved medication for treating the symptoms of HAE became available in the US for the first time in late 2008. Our immunologists have specialized training and expertise to diagnose your condition and provide relief for your symptoms accurately. Great strides have been made within the last decade to help manage this life-long condition. In an attempt to stay at the forefront of care options, we continue to conduct clinical research studies for HAE therapies.
Our clinical research studies involve medications to treat these symptoms at the forefront of current medicine and are provided at absolutely no cost, with no insurance needed to enrolled patients. Patients may also be reimbursed for time and travel and will receive care from physicians affiliated with AllerVie Clinical Research.
AllerVie collects medical history information to ensure that you meet the specific criteria to be accepted for a study. Once that is confirmed, an initial screening visit is scheduled.
At this initial visit, you’ll go over all the study information with one of our study coordinators, and specific examinations will be done to further determine if you qualify for the study.
Qualify & Onboarding
After the screening visit is complete, if you do qualify for the study, you’ll then schedule upcoming visits with the study coordinator.
From that point on, you will come to an AllerVie clinic for study visits as scheduled. You can expect to stay in constant contact with the study coordinator, as we work to ensure your safety and well-being throughout the completion of the study.
Steps to Participation
If you are interested in participating in an AllerVie clinical research study, you can expect the following:
Why AllerVie Clinical Research?
We are passionate about clinical research and paving the way for new and increasingly effective treatment options to help people live in freedom. Our patient-centered approach is founded on the partnership between patient and provider. With us, you get your own personalized team of experts in your disease with direct access to the study physician investigator.
Frequently Asked Questions
Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease. Carefully conducted clinical research studies are the safest and fastest way to find treatments that work in people and new ways to improve health. Research studies are conducted according to a plan called a protocol. A protocol describes what types of patients may enter the study including schedules of tests and procedures, drugs, dosages, length of study, and outcomes that will be measured.
Clinical research is conducted for a variety of reasons, including to see if a new drug or device is safe and effective for people to use, to compare existing treatments to determine which is better, or to study different ways to use standard (approved) treatments, so they will be more effective, easier to use, and/or decrease side effects. Clinical research helps us learn how to best extend treatments to a different population, such as children, by learning its efficacy on the new group.
Patient safety is our top concern when conducting clinical research. To protect the rights and welfare of clinical research participants, U.S. Federal Agencies including the Food and Drug Administration (FDA) & the National Institutes of Health (NIH) oversee much of the medical research and the U.S. Institutional Review Boards (IRBs) oversee the centers where clinical research studies are conducted. IRBs review and approve study protocols to ensure that a clinical trial is ethical and that volunteers’ rights are protected.
A participant in a clinical trial has access to the IRB that is overseeing the research and access to a volunteer advocate, the physician, and the staff conducting the trial.
There are many benefits to participating in clinical research, including access to potentially new research treatments, expert medical care for the condition being studied (as our investigators are generally specialists in the disease area being studied), and the ability to help others by contributing to medical research and treatment advances. Additionally, financial reimbursement for time and travel is often available to those who participate.
While there are many benefits to participation in clinical research, there are also some potential risks. These include the potential that the treatment may not be effective, participation in the trial may be demanding and time-consuming, and there may be unpleasant, serious, or even life-threatening side effects resulting from the treatment. You should weigh both the potential risks as well as the benefits and potential for positive outcomes when considering participating in clinical research. Often, the possible outcomes of cutting-edge therapies and the results they can deliver greatly outweigh the possible risks.
Be a Part of the Future of Medicine
AllerVie Clinical Research partners with patients, physicians, and pharmaceutical sponsors to contribute to the development of innovative, new therapies that connect patients and physicians to the future of medicine generating hope and cures for today and tomorrow.
“ My experience has been a delight! I instantly felt like family! Of course, I had fears in the beginning but after coming in, I was very at ease! I would tell anyone who is on the fence about participating to just do it! It CHANGED MY LIFE. I would definitely do another study to be a part of advancing meds, to be helpful to future HAE people and I love the nurses! ”
“ It has been a great experience. Everyone is really nice and it feels like they really want you to get better. Everyone is professional and caring. I never had fears before enrolling, the only thing going through my mind was if it was going to work or not. You should definitely participate. ”