|
Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes Clinical research trials and Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes. Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes clinical trial. Human subjects frequently get the finest healthcare available for their Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "I" Clinical Trials Conditions > Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes  Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes
Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes
For Condition: Agammaglobulinemia,Common Variable Immunodeficiency,Immunologic Deficiency Syndrome
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) ,
Synopsis: 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: - Lymphapheresis: This procedure is done to collect large numbers of white blood cells (lymphocytes). Blood is collected through a needle in an arm vein, similar to donating blood. The blood is separated it into its components by centrifugation (spinning), the white cells are removed, and the rest of the blood (red cells, plasma and platelets) is returned to the body, either through the same needle or through another needle in the other arm. - Blood draw: Blood may be drawn through a needle in an arm vein (venipuncture). No more than 450 milliliters (15 ounces) of blood will be collected over a 6-week period from adults, and no more than 7 ml (1 1/2 teaspoons) per kilogram (2.2 pounds) of body weight in children over the same time period. - Lymph node biopsies: Lymph node biopsies will be done only if required for diagnostic purposes. Some of the biopsy tissue may be kept for research. Up to two lymph nodes may be removed during each procedure. For the procedure, a painkiller is injected into and beneath the skin in the biopsy area, and the node is removed surgically. The incision is closed using dissolving sutures (stitches) that do not require removal. The biopsy takes about 30 minutes. Patients will be hospitalized at least overnight for observation. - Intestinal biopsies: Endoscopy and gastrointestinal biopsy will be done only if there is evidence of malabsorption. Some of the biopsy tissue may be kept for research. Patients are pre-medicated to allay anxiety, but are fully conscious during the procedure. A flexible tube is inserted into the stomach or small intestine through the mouth. The tube allows the doctor to see the intestinal mucosa and to project the image onto a TV screen. At various places in the mucosal surface, small pieces of tissue are plucked out using a small space at the tip of the endoscope. The procedure takes 30 to 60 minutes. 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.
Details: The purpose of this protocol is to carry out laboratory studies concerning the immunopathogenesis of Common Variable Immunodeficiency and related primary humoral immunodeficiency diseases.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: FOR THE PATIENT: 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. Must be 2 years old or greater. Patients with repeated infections and suspected of having an immunodeficiency syndrome. FOR FAMILY MEMBER: Be between the ages of 18 and 85 years of age. Weigh more than 110 pounds. Be in excellent health without known heart, lung, kidney, chronic anemia, or bleeding disorders. EXCLUSION CRITERIA: FOR THE PATIENT: Presence of other medical illnesses that would preclude individuals from undergoing routine diagnostic testing or testing for immunologic features of immunodeficiency. FOR FAMILY MEMBER: Presence of medical illnesses that would preclude individuals from undergoing routine blood tests. Pregnancy in female patients.
Total Enrollment: 250
Location and Contact Information:
National Institute of Allergy and Infectious Diseases (NIAID) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 890158; 89-I-0158
Study Start Date: September 14, 1989
Record last reviewed: August 8, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001244
Other Common Variable Immunodeficiency Studies:
1. Allogeneic Bone Marrow Transplantation in Patients With Primary Immunodeficiencies
2. Randomized Study of Polyethylene-Glycol-Conjugated Interleukin 2 in Patients with Common Variable Immunodeficiency
3. Immune System and Gut Abnormalities in Patients with Common Variable Immunodeficiency with and without Gastrointestinal Symptoms
4. Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes
Related Studies:
Other Common Variable Immunodeficiency Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Immune Regulation in Patients with Common Variable Immunodeficiency and Related Syndromes
|
|
|
|
|
|
|
|
