Daclizumab to Treat Chronic Immune Thrombocytopenia
Status:
Completed
Trial end date:
2004-12-01
Target enrollment:
Participant gender:
Summary
This study will evaluate the effectiveness of the drug daclizumab for treating patients with
chronic immune thrombocytopenia (ITP), a disease in which the immune system destroys
platelets (blood cells involved in the clotting process). Patients with ITP have abnormal
bruising and bleeding; severe disease can be life-threatening. For many patients, standard
drug treatments are not effective, and many of the drugs used may have significant side
effects with long-term use. Daclizumab is a genetically engineered antibody that suppresses
the immune system and has been used primarily to prevent rejection in patients who have had
organ transplants. Daclizumab has fewer side effects than other immune suppressant drugs.
Patients with ITP 18 years of age or older who have platelet counts less than
30,000/microliter and have not responded to prednisone treatment may be eligible for this
study. Candidates will be screened with a medical history, physical examination, and blood
tests.
Participants will have a 15-minute infusion of daclizumab every 2 weeks for five doses. They
will be seen by a physician at least once every 2 weeks while receiving the drug and then at
weeks 12, 20, and 32 of the study. Blood will be drawn at the 4- and 8-week visits during
treatment for diagnostic tests, and at each follow-up visit after treatment to assess the
response to therapy.
Patients who respond well to treatment will have their pre-study immunosuppressive medicines
tapered gradually one at a time starting with the 1-month follow-up visit. If their platelet
count falls to pre-treatment levels at any time during the tapering, the dose reduction will
stop and pre-study medications will be re-started, if necessary.
Phase:
Phase 2
Details
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Treatments:
Antibodies Antibodies, Monoclonal Daclizumab Immunoglobulin G