AutoImmune Hemolytic Anemia (AIHA) Research Study Enrolling!
A Phase 2 clinical study with an investigational drug for the treatment of patients with autoimmune hemolytic anemia (AIHA) is enrolling now!
If you are not responding to your current AIHA medications, have no other serious uncontrolled medical conditions, and can say yes to the following questions:
- Have you been diagnosed with warm antibody AIHA?
- Are you at least 18 years of age?
You May Be Eligible!
A Phase 2 study to evaluate the preliminary efficacy and safety of an investigational drug
(a SYK inhibitor) in the treatment of
Autoimmune Hemolytic Anemia (AIHA)
One tablet taken orally twice daily
Visit to your doctor every 2 weeks for 12 weeks
Optional extended treatment for patients with improvement in anemia
Efficacy of the drug (improvement in anemia)
Safety of the drug
Key Eligibility Criteria
Adult patients with warm antibody AIHA (may be secondary to another medical condition)
Did not respond to or did not tolerate at least one prior AIHA treatment regimen (e.g., prednisone, rituximab, splenectomy)
Anemia (low hemoglobin) with blood tests that are positive for hemolysis
• May continue to receive treatment with a stable dose of steroids, azathioprine, or ESAs (erythropoiesis stimulating agents such as epoetin alfa) during the study
Frequently Asked Questions:
In AIHA the body destroys RBCs at a greater rate than it can produce new RBCs, eventually leading to anemia (low levels of red blood cells), with symptoms such as fatigue, pale color, rapid heartbeat, and shortness of breath. In severe cases fever, chest pain, fainting, or heart failure may occur. Mild splenomegaly (enlargement of the spleen) is typical.
Warm antibody AIHA refers to the presence of antibodies that react with the red blood cell surface at body temperature. It is the most common form of AIHA, and can be either primary or secondary to an underlying disease such as systemic lupus erythematosus (SLE) or a lymphoproliferative condition such as or chronic lymphocytic leukemia (CLL) or lymphoma.
Some people with AIHA also have a similar condition, immune thrombocytopenia (ITP), in which the body attacks its own platelets—this combination of both conditions is known as Evans syndrome.
- Direct antibody (Coombs) test (DAT) positive for immunoglobulin G (IgG) antibodies. A positive DAT is a key signature of warm antibody AIHA.
- Some or all of the following indicators of active red blood cell destruction/hemolysis: elevated lactate dehydrogenase, decreased haptoglobin, increased indirect bilirubin, and increased reticulocytes (immature red blood cells).
For patients with severe AIHA without a response to other treatments, immunosuppressive agents such as cyclosporine, mycophenolate mofetil, azathioprine, and cyclophosphamide may be used.
Some patients are not effectively treated by any available therapies due to lack of a stable response, or due to severe side effects of treatment.
As with any investigational drug, there may be mild, moderate and severe risks. Side effects reported in previous studies include high blood pressure, diarrhea, dizziness, neutropenia, and abnormal liver function tests. If you would like to be part of this study, you should talk with your doctor about the side effects of the drug.
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