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NCT00005570 Clinical Trial

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

Immune Thrombocytopenic Purpura Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00005570
Other study ID # 000120
Secondary ID 00-H-0120
Status Completed
Phase N/A
First received April 22, 2000
Last updated March 3, 2008
Start date April 2000
Est. completion date July 2000

Study information
Verified date April 2000
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 200
Est. completion date July 2000
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

N/A

Related Conditions & MeSH terms

Locations
Country Name City State
United States National Heart, Lung and Blood Institute (NHLBI) Bethesda Maryland

Sponsors (1)
Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kelton JG, Gibbons S. Autoimmune platelet destruction: idiopathic thrombocytopenic purpura. Semin Thromb Hemost. 1982 Apr;8(2):83-104. Review. — View Citation

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