Clinical Trials Logo

Agammaglobulinemia clinical trials

View clinical trials related to Agammaglobulinemia.

Filter by:

NCT ID: NCT02234791 Not yet recruiting - Clinical trials for Agammaglobulinemia, BTK

Mutation of the BTK Gene and Genotype-phenotype Correlation of Chinese Patients With X-Linked Agammaglobulinemia

Start date: September 2014
Phase: N/A
Study type: Observational [Patient Registry]

X-linked agammaglobulinemia (XLA) is a humoral primary immunodeficiency in which affected patients have very low levels of peripheral B cells and a profound deficiency of all immunoglobulin isotypes. Mutations in the gene encoding for Bruton's tyrosine kinase (Btk) are responsible for most of the gammaglobulinemia. We tend to investigate the gene mutation and clinical features of Chinese X-linked agammaglobulinemia (XLA) patients, and also examined the relationship between specific Btk gene mutations and severity of clinical presentation.

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: NCT02022696 Completed - Clinical trials for Adenosine Deaminase Deficiency

Treatment of SCID Due to ADA Deficiency With Autologous Transplantation of Cord Blood or Hematopoietic CD 34+ Cells After Addition of a Normal Human ADA cDNA by the EFS-ADA Lentiviral Vector

Start date: December 16, 2013
Phase: Phase 1
Study type: Interventional

This is a clinical gene transfer study that aims to verify the safety and efficacy of the use of the EFS-ADA lentiviral vector to introduce the human adenosine deaminase (ADA) gene into the hematopoietic progenitors of patients affected with severe combined immunodeficiency due to ADA deficiency. The EFS-ADA vector expresses the human ADA cDNA under the control of the elongation factor alpha short promoter (EFS). In addition, this protocol will examine the effects of the ADA gene transfer on the immune system of treated patients. Patients with ADA deficiency and ineligible for matched sibling allogeneic bone marrow transplantation are eligible to participate in the study. To increase engraftment and selected advantage or gene-corrected cells, busulfan will be used as a cytoreductive agent. Enzyme replacement (PEG-ADA) will be discontinued 30 days after infusion of gene-corrected cells. CD34+ hematopoietic progenitors will be isolated from the patient bone marrow, peripheral blood or cord blood, exposed to lentiviral vector-mediated gene transfer and re-infused into the patient through a peripheral vein. Clinical, immunological and molecular follow-up studies will assess safety, toxicity, and efficacy of the procedure.

NCT ID: NCT01981785 Active, not recruiting - Autoimmune Diseases Clinical Trials

Investigation of Immune Disorders and Deficiencies

Start date: December 2012
Phase: N/A
Study type: Observational

The immune system is an intricate system comprised of specialized cells, proteins, tissues and organs. Proper functioning is critical to the body's ability to defend itself against harmful pathogens. Immunological disorders and deficiencies are defects in the immune system that lead to abnormal immune responses. Abnormal immune responses could be derived from immune deficiencies, dysregulations or hypersensitivities. The overall goal of this research study is to identify the mechanisms of primary immune deficiencies and immune disorders at the genetic, cellular and molecular level, using novel analytic techniques to be performed on immune cells derived from blood samples. The knowledge gained from the aims of this study could lead to better diagnostics and identify novel targets for therapeutic interventions.

NCT ID: NCT01963143 Completed - Clinical trials for Common Variable Immunodeficiency

Bioequivalence Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Gammaplex® 10 and Gammaplex® 5% in Primary Immunodeficiency Diseases

GMX07
Start date: February 2014
Phase: Phase 3
Study type: Interventional

The primary objective is to demonstrate the bioequivalence of Gammaplex® 10 intravenous immunoglobulin (IGIV) and Gammaplex® 5% IGIV with respect to area under the curve within a 28-day dosing interval (AUC0-28) in a cohort of adult subjects. The secondary objectives are to demonstrate the bioequivalence of Gammaplex® 10 IGIV and Gammaplex® 5% IGIV with respect to area under the curve within a 21-day dosing interval (AUC0-21) in adult subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV and Gammaplex 5% IGIV including Immunoglobulin G (IgG) trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV and Gammaplex 5% IGIV in adults subjects; to assess the pharmacokinetics of Gammaplex 10 IGIV including IgG trough levels and to investigate the safety and tolerability of Gammaplex 10 IGIV in pediatric subjects.

NCT ID: NCT01924169 Terminated - Clinical trials for Hematologic Disorder

Lenalidomide as Immune Adjuvant in Patient's With Chronic Lymphocytic Leukemia (CLL)

Start date: November 24, 2014
Phase: Phase 2
Study type: Interventional

The goal of this clinical research study is to learn if lenalidomide can increase the level of immunoglobulins (parts of the blood that may help to improve the immune system's function) and/or will improve the protective effect of the flu and pneumonia vaccines in patients with CLL.

NCT ID: NCT01884311 Completed - Clinical trials for Common Variable Immunodeficiency

Pharmacokinetics (PK) and Safety of Subgam-VF in Primary Immunodeficiency Diseases

SCIG03
Start date: August 20, 2015
Phase: Phase 3
Study type: Interventional

The main objective of the study is to determine the pharmacokinetics profile of Subgam-VF. The secondary objectives are to assess the safety of Subgam-VF and refine the dose adjustment coefficient for Subgam-VF needed for subjects switching from prior intravenous immunoglobulin (IGIV) therapy.

NCT ID: NCT01821781 Recruiting - Clinical trials for Chronic Granulomatous Disease

Immune Disorder HSCT Protocol

Start date: March 2013
Phase: Phase 2
Study type: Interventional

This study hypothesizes that a reduced intensity immunosuppressive preparative regimen will establish engraftment of donor hematopoietic cells with acceptable early and delayed toxicity in patients with immune function disorders. A regimen that maximizes host immune suppression is expected to reduce graft rejection and optimize donor cell engraftment.

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).