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| Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00005570 |
Purpose
This study involves the collection of blood samples from patients with immune thrombocytopenic purpura (ITP) to evaluate the relationship between platelet counts, blood levels of a hormone called thrombopoietin that controls platelet production by the bone marrow, and blood levels of antibodies against thrombopoietin that could interfere with the action of this hormone. Blood samples will also be stored if separately agreed to by the patient for analysis of genes that might affect platelet production. At a single outpatient clinic visit, patients will have a medical history taken, and blood samples drawn for testing. Results from this study may help further understand the control of platelet production in patients with ITP, and suggest new therapeutic approaches.
| Condition |
|---|
|
Purpura, Thrombocytopenic, Idiopathic Immune Thrombocytopenic Purpura |
| Study Type: | Observational |
| Official Title: | An Epidemiological Study of Subjects With Immune Thrombocytopenic Purpura to Evaluate the Relationship Between Platelet Counts, Endogenous Thrombopoietin Levels, Endogenous Anti-Thrombopoietin Antibodies, and Selected Autoimmune Markers |
| Estimated Enrollment: | 200 |
| Study Start Date: | April 2000 |
| Estimated Study Completion Date: | July 2000 |
This study involves the collection of blood samples from patients with immune thrombocytopenic purpura (ITP) to evaluate the relationship between platelet counts, blood levels of a hormone called thrombopoietin that controls platelet production by the bone marrow, and blood levels of antibodies against thrombopoietin that could interfere with the action of this hormone. Blood samples will also be stored if separately agreed to by the patient for analysis of genes that might affect platelet production. At a single outpatient clinic visit, patients will have a medical history taken, and blood samples drawn for testing. Results from this study may help further understand the control of platelet production in patients with ITP, and suggest new therapeutic approaches.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Diagnosis of ITP, based on the history, physical examination, complete blood count, and examination of the peripheral smear, which should exclude other causes of thrombocytopenia. These criteria for ITP are based on the American Society of Hematology practice guideline for ITP.
Subjects 5 years of age or older.
Before the study specific procedure, the subject or legally acceptable representative must give written informed consent(s) for participation in the study.
No subjects with documented history of Human Immunodeficiency Virus (HIV) or Hepatitis.
No subjects with known underlying causes of thrombocytopenia such as lupus erythematosus, autoimmune thyroid disorders, drug-induced thrombocytopenia, bone marrow disorders, and liver disease.
No psychiatric or addictive disorders that compromise the subject's ability to give truly informed consent for participation in the study.
Contacts and Locations More Information
| Study ID Numbers: | 000120, 00-H-0120 |
| Study First Received: | April 22, 2000 |
| Last Updated: | March 3, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005570 |
| Health Authority: | United States: Federal Government |
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Bleeding Cytokines Immune Response Pharmacogenomic |
Serum Antibodies ITP Immune Thrombocytopenia Purpura |
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Purpura Autoimmune Diseases Immune thrombocytopenia Hematologic Diseases Blood Coagulation Disorders Blood Platelet Disorders Hemorrhage Hemostatic Disorders |
Purpura, Thrombocytopenic Thrombocytopathy Signs and Symptoms Antibodies Thrombocytopenia Hemorrhagic Disorders Purpura, Thrombocytopenic, Idiopathic Immunoglobulins |
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Skin Manifestations Immunologic Factors Immune System Diseases Physiological Effects of Drugs Pharmacologic Actions |
