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Hypogammaglobulinemia clinical trials

View clinical trials related to Hypogammaglobulinemia.

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NCT ID: NCT03401268 Completed - Clinical trials for Hypogammaglobulinemia

Subcutaneous Ig in Allogeneic Stem Cell Transplant Recipients

ScIGalloHCT
Start date: February 1, 2018
Phase: N/A
Study type: Interventional

Tolerability of home subcutaneous immunoglobulin (ScIG) for replacement therapy for hypogammaglobulinemia in allogeneic HCT patients. A financial analysis comparing the cost of ScIG with intravenous immunoglobulin (IVIG) will also be performed.

NCT ID: NCT02508584 Completed - Infection Clinical Trials

Personalized Immunotherapeutic for Antibiotic-resistant Infection

Start date: April 12, 2016
Phase: Early Phase 1
Study type: Interventional

M. A. suffers from hypogammaglobulinemia that has been complicated by refractory Mycoplasma hominis septic arthritis. He has been receiving the antibiotic valnemulin under Emergency Investigational New Drug (eIND) 114686 following many prior treatments with standard antibiotics. M.A. has also been receiving intravenous immunoglobulin (IVIG) replacement. The antibiotic and IVIG have been helpful, but not sufficient for cure. Antibodies have been shown to be critical for defense against mycoplasma. Hyperimmune serum against mycoplasma isolated from rabbit or goat has been effective in cases of chronic erosive arthritis in the setting of immune deficiency, and in some cases resulted in cures. The investigators propose to use M. hominis isolated from M. A. to vaccinate one transgenic cow (developed by SAB Biotherapeutics), purify human antibody after vaccination, test the purified antibody in killing assays to confirm potency, and then administer the purified human IgG to M. A. after FDA compassionate use IND application and local Institutional Review Board (IRB) approval.

NCT ID: NCT02231879 Completed - Infections Clinical Trials

Plerixafor Versus G-CSF in the Treatment of People With WHIM Syndrome

Start date: October 14, 2014
Phase: Phase 2/Phase 3
Study type: Interventional

Background: - WHIMS (Warts, Hypogammaglobulinemia, Infections, and Myelokathexis Syndrome) is a rare disease. It can cause cancers, infections, and warts. Researchers want to see if a drug called plerixafor can treat WHIMS. Objective: - To compare plerixafor versus granulocyte colony stimulating factor (G-CSF) for preventing infections in people with WHIMS. Eligibility: - People ages 10-75 with WHIMS who have a CXCR4 gene mutation. Design: - Participants will be screened with a medical history, physical exam, and blood and urine tests. They may have heart and spleen tests and body scans. They may have samples of skin or warts taken. Researchers may take photographs of warts. - Participants will start twice daily self-injections of G-CSF. Their doctors will decide the dosage. - Initial Period (4-12 weeks) - Participants will: - continue the injections and their usual antibiotics and/or immunoglobulin - have blood drawn - keep a daily health diary - Participants will visit the clinic for 2 days without injections. - Adjustment Period 1 (8 weeks): - Participants will: - continue twice daily injections from home - continue the daily health diary - have blood tests every 2 weeks. - Treatment Year 1: - Participants will - receive either plerixafor or G-CSF injections twice daily - continue the health diary - have blood tests every 2 months - visit the clinic about every 4 months - At the end of year 1, participants will visit the clinic for an evaluation. They will switch to the other study drug. They will have an 8-week adjustment and 1-year treatment period. - At the end of year 2, participants will visit the clinic to complete their injections and go back to their previous G-CSF regimen. Participants will continue their daily health diary and have blood tests for 5-6 months.

NCT ID: NCT02043379 Completed - Clinical trials for Congenital Heart Disease

Intravenous Immunoglobulin for Early Prevention of Cardiopulmonary Bypass Induced Hypogammaglobulinemia in Infants and Neonates

Start date: May 2014
Phase: N/A
Study type: Interventional

The purpose of this study protocol is to determine if administering Intravenous Immunoglobulin (IVIG) for treatment of cardiopulmonary bypass (CPB) induced hypogammaglobulinemia in the early post-operative period can impact post-surgical outcomes (i.e., infection, fluid overload, and associated morbidities).

NCT ID: NCT01581593 Completed - Clinical trials for Primary Immunodeficiency

Efficacy and Safety Study of Kedrion IVIG 10% to Treat Subjects With Primary Immunodeficiency (PID)

Start date: November 12, 2012
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine whether Kedrion IVIG 10% (an immunoglobulin solution) is effective in treating Primary Immunodeficiency (PID).

NCT ID: NCT01002755 Completed - Fatigue Clinical Trials

Lenalidomide and Ofatumumab in Treating Participants With Previously Treated Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Start date: January 19, 2010
Phase: Phase 2
Study type: Interventional

This phase II trial studies how well lenalidomide and ofatumumab work in treating participants with previously treated chronic lymphocytic leukemia or small lymphocytic lymphoma. Drugs used in chemotherapy, such as lenalidomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as ofatumumab, may interfere with the ability of tumor cells to grow and spread. Giving lenalidomide and ofatumumab may work better in treating participants with chronic lymphocytic leukemia or small lymphocytic lymphoma

NCT ID: NCT00278954 Completed - Clinical trials for Primary Immunodeficiency

Efficacy, Safety and Pharmacokinetics of Gammaplex in Primary Immunodeficiency Diseases.

Start date: January 2006
Phase: Phase 3
Study type: Interventional

The main objective of this study is to see if GAMMAPLEX is efficacious with respect to Food and Drug Administration (FDA) minimal requirements (no more than 1 serious, acute, bacterial infection per subject per year) in subjects with Primary Immunodeficiency Diseases (PID). The secondary objectives are to assess the safety and tolerability of GAMMAPLEX and to determine if GAMMAPLEX has a pharmacokinetic (PK) profile comparable with that of intact Immunoglobulin G (IgG) in subjects with PID.

NCT ID: NCT00161993 Completed - Clinical trials for Primary Immunodeficiency Diseases (PID)

Safety, Pharmacokinetic and Efficacy Study of a 10% Triple Virally Reduced Intravenous Immune Globulin Solution in Patients With Primary Immunodeficiency (Hypo- or Agammaglobulinemia)

Start date: June 13, 2002
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the pharmacokinetics, efficacy and safety of Immune Globulin Intravenous (Human), 10% TVR (Triple Virally Reduced) Solution in subjects with primary immunodeficiency (PID) manifesting as hypo- or agammaglobulinemia. Subjects are treated every 21 days and receive a total of 12 infusions: for the first 3 infusions subjects receive GAMMAGARD S/D to ensure a steady-state and to acquire data with a licensed product; for the remaining 9 infusions subjects receive IGIV, 10% TVR Solution.

NCT ID: NCT00138697 Completed - Clinical trials for Hypogammaglobulinemia

Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients

Start date: May 2001
Phase: Phase 2/Phase 3
Study type: Interventional

The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L, were studied in patients with hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin substitution therapy.

NCT ID: NCT00137748 Completed - Clinical trials for Hypogammaglobulinemia

Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients

Start date: January 2001
Phase: Phase 2/Phase 3
Study type: Interventional

This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.