Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00128882
Status:
COMPLETED
Last Update Posted:
2009-02-03
First Post:
2005-08-08
Brief Title:
Treatment of Idiopathic Thrombocytopenic Purpura ITP With Subcutaneously Administered Anti-D
Sponsor:
University of Aarhus
Organization:
University of Aarhus
Study Overview
Official Title:
Treatment of Idiopathic Thrombocytopenic Purpura in Children With Subcutaneously Administered Anti-D
Status:
COMPLETED
Status Verified Date:
2009-02
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:
The purpose of this study is to describe the effect of anti-D on symptoms and platelet count in children suffering from unexplainable low platelet counts when anti-D is administered as an injection under the skin The hypothesis is that the injection with anti-D under the skin is as effective as anti-D given in a vein
Detailed Description:
Background
Idiopathic thrombocytopenic purpura ITP in children is considered a benign hematological disease The incidence is approximately 50 cases a year in Denmark Approximately 25 will experience chronic disease Follow up and treatment of these patients is not centralized
The drug of choice is intravenous IgG IVIG for treatment of ITP The side effects are flu-like symptoms and in rare cases aseptic meningitis Another option is intravenous anti-D if the child is rhesus positive Anti-D is primarily used in North America The effect of Anti-D is comparable with IVIG when considering the time it takes to bring the platelet count above 50000μL Anti-D also causes flu-like symptoms Establishing an iv access is a disadvantage to both IVIG and anti-D For both treatments mechanism of action is not finally described
Subcutaneous IgG substitution therapy is used for patients suffering from agammaglobulinaemia It is therefore known that immunoglobulin uptake is possible after subcutaneous administration Subcutaneous anti-D has been tried in few patients suffering from chronic thrombocytopenia with positive results
IVIG treatment is expensive compared to anti-D Treatment of a 20 kg child costs approximately 17000 Dkr for IVIG and 2500 Dkr for anti-D
Hypothesis
Subcutaneous administered anti-D is as effective as IVIGiv anti-D
Subcutaneous administered anti-D has fewer less severe side effects than IVIGiv anti-D
Purpose
To document the effect of subcutaneous anti-D
Describe complications
Describe aspects of the mechanism of action
Material and Methods
Children are eligible if admitted to a pediatric department in Denmark for diagnosis observation or treatment of acute or chronic ITP Examination and diagnostic work up is similar throughout the country but not identical No specific tests are required for diagnosis If treatment is indicated rhesus positive children are treated with subcutaneous anti-D Rhesus negative children are treated according to local guidelines Specified follow-up on all children is mandatory For research purposes one blood sample form all children is collected and from children who receive medical treatment several blood samples are collected Analysis for changes in immunological signaling peptides will be performed with special attention to the mechanism of action of anti-D
Idiopathic thrombocytopenic purpura ITP in children is considered a benign hematological disease The incidence is approximately 50 cases a year in Denmark Approximately 25 will experience chronic disease Follow up and treatment of these patients is not centralized
The drug of choice is intravenous IgG IVIG for treatment of ITP The side effects are flu-like symptoms and in rare cases aseptic meningitis Another option is intravenous anti-D if the child is rhesus positive Anti-D is primarily used in North America The effect of Anti-D is comparable with IVIG when considering the time it takes to bring the platelet count above 50000μL Anti-D also causes flu-like symptoms Establishing an iv access is a disadvantage to both IVIG and anti-D For both treatments mechanism of action is not finally described
Subcutaneous IgG substitution therapy is used for patients suffering from agammaglobulinaemia It is therefore known that immunoglobulin uptake is possible after subcutaneous administration Subcutaneous anti-D has been tried in few patients suffering from chronic thrombocytopenia with positive results
IVIG treatment is expensive compared to anti-D Treatment of a 20 kg child costs approximately 17000 Dkr for IVIG and 2500 Dkr for anti-D
Hypothesis
Subcutaneous administered anti-D is as effective as IVIGiv anti-D
Subcutaneous administered anti-D has fewer less severe side effects than IVIGiv anti-D
Purpose
To document the effect of subcutaneous anti-D
Describe complications
Describe aspects of the mechanism of action
Material and Methods
Children are eligible if admitted to a pediatric department in Denmark for diagnosis observation or treatment of acute or chronic ITP Examination and diagnostic work up is similar throughout the country but not identical No specific tests are required for diagnosis If treatment is indicated rhesus positive children are treated with subcutaneous anti-D Rhesus negative children are treated according to local guidelines Specified follow-up on all children is mandatory For research purposes one blood sample form all children is collected and from children who receive medical treatment several blood samples are collected Analysis for changes in immunological signaling peptides will be performed with special attention to the mechanism of action of anti-D
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 |
|---|---|---|---|
| 2612-2447 | None | None | None |
| 2003179 | None | None | None |