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Hypogammaglobulinemia clinical trials

View clinical trials related to Hypogammaglobulinemia.

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NCT ID: NCT05678621 Recruiting - Clinical trials for Haematological Malignancy

Role of Antibiotic Therapy or Immunoglobulin On iNfections in hAematoLogy: Immunoglobulin Stopping or Extension

RATIONALISE
Start date: November 30, 2022
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of the study is to find out if patients with blood cancers receiving immunoglobulin (Ig) for the purpose of preventing infections can safety stop immunoglobulin after six months of therapy, and take oral antibiotics instead to prevent serious infections. Patients may be eligible to join this study if they are aged 18 years or above, have an acquired hypogammaglobulinaemia secondary to a haematological malignancy, and have been receiving intravenous or subcutaneous Ig for longer than 6 consecutive months. Participants will be randomised (allocated by chance) to one of three treatment groups, as follows: - Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to take every day (ARM A) - Stop immunoglobulin (IVIg or SCIg) and be given oral antibiotics to keep at home to use as soon as symptoms of an infection develop (ARM B) - Continue receiving immunoglobulin (IVIg or SCIg) - this is the usual care group (ARM C) The duration of each treatment is for 12 months from study entry. Participants will be asked to attend a screening/baseline visit so that their treating clinician can assess their eligibility for the trial and collect baseline data. If eligible for the trial, participants will then be randomly allocated to one of the three treatment groups. Once randomised, active participation in the study will last for 13 months. During this period, participants will be asked to return to the hospital for a study visit every 3 months, with monthly telephone visits to check-in on your progress between each in-person visit. Participants will also be asked to complete a study diary, recording treatment compliance and signs/symptoms of infection experienced throughout the study period. Types of assessments and data collected will include: Medical history, demographics, physical examination, blood tests, stool sample, quality of life questionnaires, information about your general health, hospitalisations, medications and procedures. In order to assess and compare the cost-effectiveness of the treatment groups, the study team will also request authorisation from participants to access their Medicare Benefits Schedule (MBS), Pharmaceutical Benefits Scheme (PBS), and Australian Immunisation Register (AIR) data.

NCT ID: NCT05645107 Recruiting - Clinical trials for Bacterial Infections

A Study to Evaluate Efficacy, Safety, and Pharmacokinetics of XEMBIFY® Plus Standard Medical Treatment (SMT) Compared to Placebo Plus SMT to Prevent Infections in Participants With Hypogammaglobulinemia and Recurrent or Severe Infections Associated With B-cell Chronic Lymphocytic Leukemia

Start date: December 26, 2022
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to evaluate whether weekly administered XEMBIFY® plus Standard Medical Treatment (SMT) over a one-year period will reduce the rate of major bacterial infections per participant per year in participants with hypogammaglobulinemia (HGG) associated with B-cell chronic lymphocytic leukemia (CLL) in comparison to the Placebo plus SMT group.

NCT ID: NCT05357781 Recruiting - Multiple Sclerosis Clinical Trials

Immunoglobulin Deficiency a Treatable Cause of Fatigue in Patients With Multiple Sclerosis (MS)?

FatIgG
Start date: July 1, 2022
Phase:
Study type: Observational

The investigators hypothesize that hypogammaglobulinemia (defined as IgG serum concentration <7.0g/L) is a treatable cause of fatigue in people with MS: The primary objective is to prove the link between hypogammaglobulinemia and fatigue in patients with multiple sclerosis. The secondary objective is to show that fatigue is mediated via frequent infections in people with MS and hypogammaglobulinemia.

NCT ID: NCT04502030 Recruiting - Clinical trials for Chronic Lymphocytic Leukemia

Double-blind, Randomized, Placebo-controlled, Prospective Phase III Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients With Chronic Lymphocytic Leukemia ("PRO-SID" Study)

Start date: October 5, 2020
Phase: Phase 3
Study type: Interventional

Study Evaluating Efficacy and Safety of Panzyga in Primary Infection Prophylaxis in Patients with Chronic Lymphocytic Leukemia

NCT ID: NCT04447937 Not yet recruiting - Multiple Sclerosis Clinical Trials

Immunodeficiency in MS

Start date: June 29, 2020
Phase:
Study type: Observational

The purpose of this study is to identify if there is a relationship between multiple sclerosis disease-modifying therapy exposure, immunodeficiencies, and infection risk in subjects living with MS.

NCT ID: NCT04283747 Recruiting - Multiple Sclerosis Clinical Trials

Rituximab-Induced Hypogammaglobulinemia in Multiple Sclerosis

Start date: February 28, 2020
Phase:
Study type: Observational

B cells are considered major contributors to multiple sclerosis (MS) pathogenesis, a role that has taken on renewed importance with the advent of B-cell-depleting therapies. Rituximab is being increasingly utilized as an off-label treatment option across MS patients . In addition, there have been increasing reports of rituximab causing hypogammaglobulinaemia and antibody deficiency across a variety of conditions including MS and related neuroinflammatory disorders. Therefore, the purpose of this study is to evaluate the rate of hypogammaglobulinemia in rituximab-treated MS adult patients and to assess the correlation with vaccination response during the treatment.

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).