Ongoing Clinical Trials for Selective Polysaccharide Antibody Deficiency
There is currently 1 ongoing clinical trial for selective polysaccharide antibody deficiency. This trial is investigating whether higher doses of immunoglobulin therapy can help protect the lungs and slow the progression of lung disease in patients with primary antibody deficiencies. The study is being conducted in the Netherlands and includes patients aged 8 to 60 years who are already receiving immunoglobulin replacement therapy.
Clinical trial locations
Study on the Effect of Human Normal Immunoglobulin on Lung Disease in Patients with Primary Antibody Deficiency
This clinical trial is investigating how immunoglobulin therapy affects lung disease in people with Primary Antibody Deficiency. This condition makes it difficult for the body to produce enough antibodies to fight infections, which can lead to repeated respiratory infections and, over time, chronic lung damage.
Main inclusion criteria: Participants must be between 8 and 60 years old and have a confirmed diagnosis of Primary Antibody Deficiency or Common Variable Immunodeficiency Disorder. They should either need immunoglobulin replacement therapy or already be receiving it, with current dosing between 0.25 and 0.6 grams per kilogram every 3 to 4 weeks. Participants must be under the care of a doctor at one of the participating centers and provide written informed consent to join the study.
Main exclusion criteria: The trial excludes patients who do not have a primary antibody deficiency or who have other types of immune system problems not specified in the study. Those outside the required age range or who are considered part of a vulnerable population requiring special protection are also excluded.
Focus and goal: The main goal of this study is to determine whether higher doses of immunoglobulin can better protect against the progression of lung disease. Participants will receive either a standard dose or a higher dose of immunoglobulin therapy. Throughout the study, researchers will monitor lung health through regular check-ups and CT scans to assess airway disease and lung damage. Participants will keep a daily diary to track respiratory symptoms and report any missed days from work or school due to illness. The study will also evaluate the overall health costs and quality of life for participants using questionnaires.
Investigational drugs: The study uses Human Normal Immunoglobulin, a substance derived from blood that helps boost the immune system by providing antibodies. Several medications containing this substance are being tested, including Nanogam, HyQvia, Privigen, KIOVIG, Gammanorm, CUTAQUIG, GAMMAGARD S/D, Hizentra, Octagam, and Cuvitru. These medications can be given either intravenously (through a vein) or subcutaneously (under the skin), depending on what works best for each participant.
The study follows participants through several phases. After confirming eligibility and establishing baseline health status, including lung function tests and CT scans, participants begin their assigned immunoglobulin treatment. Regular monitoring includes tracking respiratory infections and maintaining symptom diaries. Follow-up CT scans are performed at the end of the study to measure any changes in lung disease from the beginning. The research team will also conduct immunological laboratory tests to evaluate changes in immune function throughout the trial.
Summary
Currently, there is one active clinical trial for selective polysaccharide antibody deficiency and related primary antibody deficiencies. The trial is located in the Netherlands and focuses specifically on understanding how different doses of immunoglobulin therapy impact lung disease progression. The study includes a comprehensive approach to monitoring, combining objective measures like CT scans with patient-reported outcomes through daily diaries and quality of life questionnaires. Multiple immunoglobulin products are being used in the trial, reflecting the variety of treatment options available to patients. This research aims to provide valuable information about the effectiveness and cost-efficiency of different immunoglobulin dosing strategies for managing these conditions and protecting lung health.
