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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 3, 1999 | ||||||||
| Last Updated Date | August 11, 2009 | ||||||||
| Start Date ICMJE | September 1989 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
Safety and efficacy. | ||||||||
| Change History | Complete list of historical versions of study NCT00001244 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Immune Regulation in Patients With Common Variable Immunodeficiency and Related Syndromes | ||||||||
| Official Title ICMJE | Studies of Immune Regulation in Patients With Common Variable Immunodeficiency and Related Humoral Immunodeficiency Syndromes | ||||||||
| Brief Summary | This study will explore the cause of immunodeficiency in common variable immunodeficiency (CVI) and other related immunodeficiency syndromes-IgA deficiency, hyper IgM syndrome, thymoma and agammaglobulinemia, hypogammaglobulinemia associated with Epstein-Barr infection, and others-to better focus on how to correct the underlying defect. Patients with CVI and their family members may participate in this study. Family members must be between the ages of 18 and 85, in good health and weigh at least 110 pounds. Patients will receive standard medical care for their illness. Procedures may include a medical history and physical examination, routine blood tests, stool examination for infectious agents, lung function tests, chest and sinus X-rays. Treatment may include administration of immune serum globulin, antibiotics for infections, and anti-inflammatory drugs, if needed. In addition, patients may undergo the following:
Some of the blood collected may be used for genetic tests. Some blood and tissue samples may be stored for future research-labeled with a code, such as a number, that only the study team can link to the patient. Participating family members will provide a medical history, and their pulse, blood pressure and temperature will be taken. They will have 10 to 120 ml (1/3 to 4 ounces) of blood drawn from a vein in the arm. Blood samples may be taken on repeated occasions as long as the relative remains in the study. The blood will be used for research that may involve development of diagnostic tests for CVI, evaluation of the structure and function of normal blood cells for comparison with those of patients with CVI, and studies to try to determine possible genetic factors involved in susceptibility to CVI. |
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| Detailed Description | The purpose of this protocol is to carry out laboratory studies concerning the immunopathogenesis of Common Variable Immunodeficiency (CVI) and related primary humoral immunodeficiency diseases. Additionally, we aim to document and track the progression of known complications of this primary immunodeficiencv. Complications associated with CVID include recurrent respiratory, and gastrointestinal bacterial infections, pulmonary insufficiency, lymphoid malignancy, and various autoimmune manifestations. Patients with CVI and related B Cell immunodeficiencies will be enrolled into this natural history study. Protocol procedures will include baseline measurements of and changes in lab and radiographic studies. Changes in the patients' clinical state will be measured to determine the precursors of disease complications. This may lead to developments in improving preventive measures and novel treatment options for this population. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 250 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE |
Must have a verifiable diagnosis of common variable immune deficiency as defined by a decrease both in IgG and at least one other Ig isotype to below two standard deviations of normal control levels. Or B cell immunodeficiencies related to CVI (defined as selective IgA deficiency, hyper IgM syndrome, thymoma and agammaglobulinemia, and hypogammaglobulinemia associated with Epstein-Barr virus infection) or hypogammaglobulemia associated with other related immunodeficiencies. Must be 2 years old or greater. Patients with repeated infections and suspected of having an immunodeficiency syndrome. Patients must have a primary medical care provider as a criterion for inclusion into this study. EXCLUSION CRITERIA: Presence of other medical illnesses that would preclude individuals from undergoing routine diagnostic testing or testing for immunologic features of immunodeficiency. |
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| Gender | Both | ||||||||
| Ages | 2 Years to 85 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00001244 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 890158, 89-I-0158 | ||||||||
| Study Sponsor ICMJE | National Institute of Allergy and Infectious Diseases (NIAID) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | July 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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