Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049725
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2002-11-12
Brief Title:
Daclizumab to Treat Chronic Immune Thrombocytopenia
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Study of Daclizumab in Chronic Immune Thrombocytopenia ITP
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 30000microliter 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
Patients with ITP 18 years of age or older who have platelet counts less than 30000microliter 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
Detailed Description:
Immune thrombocytopenia ITP is an acquired blood disease in which the individuals immune system destroys platelets the blood cells responsible for clotting A number of standard treatments exist to decrease the destruction of platelets including drugs such as the steroid hormone prednisone or removal of the spleen Over a third of adult patients will not maintain adequate platelet counts with these treatments Alternative treatments may be indicated due to bleeding symptoms or baseline platelet counts less than 20000ul a level at which spontaneous serious bleeding can occur Therapy for chronic ITP is generally effective in less than 30-50 of patients however and most of these agents have significant toxicities with long-term use are expensive or their administration interferes with daily activities
Daclizumab is a humanized anti-interleukin-2 receptor monoclonal antibody that works by targeting and impairing activated T lymphocytes a subset of white blood cells that has been thought to be involved in the development and maintenance of ITP Daclizumab is a well-tolerated and time-limited therapy and is easily administered on an outpatient basis The purpose of this study is to test the efficacy of daclizumab as either a sole agent in the treatment of chronic symptomatic ITP or as a treatment that might allow a decrease or discontinuation of medications such as prednisone
Daclizumab is a humanized anti-interleukin-2 receptor monoclonal antibody that works by targeting and impairing activated T lymphocytes a subset of white blood cells that has been thought to be involved in the development and maintenance of ITP Daclizumab is a well-tolerated and time-limited therapy and is easily administered on an outpatient basis The purpose of this study is to test the efficacy of daclizumab as either a sole agent in the treatment of chronic symptomatic ITP or as a treatment that might allow a decrease or discontinuation of medications such as prednisone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-CC-0046 | None | None | None |