A Phase 4 interventional study of Hizentra in Common Variable Immunodeficiency, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.
Sponsored by University of Alabama at Birmingham · Phase 4, Interventional, and Treatment
Although there is evidence in the literature that gammaglobulin replacement therapy can lead to a reduction in the prevalence of pulmonary infection and improved lung function, there is no published study to guide immunologists regarding the use of spirometry in titrating IG therapy to assist in the management of immunodeficiency patients with regards to gammaglobulin replacement therapy.
The investigators propose to study the use of spirometry to identify patients that could potentially benefit from an increase in IGRT. The investigators will identify 22 common variable immune deficiency (CVID) study subjects on stable IGRT replacement therapy equivalent to 0.40 to 0.60 gm/kg per 4 weeks who have evidence of mild to moderate obstruction as assessed by an FEF25-75% between 50% and 80% of predicted. Patients who are on Hizentra will be preferentially recruited. Of these 22, 11 will be identified at random and treated for 6 months at their current dose (control population). The remaining 11 study subjects (treatment group) will have their level of IGRT increased by the equivalent of 0.05 gm/kg in dose per 4 weeks, adjusted for bioavailability as per manufacturer's instructions. On average, rounded up to the nearest gram, this will typically increase their dose of Hizentra by 2 gm per week.
The key finding of the published retrospective study was that common variable immune deficiency (CVID) patients with moderate, presumed reversible, obstruction on stable, therapeutic doses of IgG who exhibited a decline in lung function from one clinic visit to the next responded to an increased dose of IgG with an improvement in lung function as assessed by spirometry.
The investigators now wish perform a clinical trial to assess whether primary antibody deficiency patients receiving IGRT who fit in this range of obstruction, i.e. an FEF25-75% that is 50-80% of predicted, will demonstrate an increase in lung function, as assessed by spirometry, after increasing the dose of IGRT. The presumption is that obstruction at this level is most likely due to the effects of subclinical infections that can be reduced or avoided by increasing the amount of gammaglobulin received by the patients.
Exclusion Criteria:
11 subjects will be treated for 6 months at their current dose of Hizentra
11 subjects will have their level of immunoglobulin replacement therapy increased by the equivalent of 0.05 gm/kg in dose per 4 weeks, adjusted for bioavailability as per manufacturer's instructions. On average, rounded up to the nearest gram, this will typically increase their dose of Hizentra by 2 gm per week.
Drug: Hizentra
subjects level of immunoglobulin replacement therapy will be adjusted for bioavailability as per manufacturer's instructions
Also known as: subcutaneous gammaglobulin therapy
FEV1 at baseline
Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at baseline.
Time frame: baseline
FEV1 at 3 months
Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at three months into the study.
Time frame: 3 months
FEV1 at 6 months.
Pulmonary function will be measured by forced expiratory volume in one second (FEV1) at six months into the study.
Time frame: 6 months
FVC at baseline
Pulmonary function will be measured by forced vital capacity (FVC) at baseline.
Time frame: baseline
FVC at 3 months
Pulmonary function will be measured by forced vital capacity (FVC) at three months.
Time frame: 3 months
FVC at 6 months.
Pulmonary function will be measured by forced vital capacity (FVC) at six months.
Time frame: 6 months
FEF25-75% at baseline
Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at baseline.
Time frame: baseline
FEF25-75% at 3 months
Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at 3 months.
Time frame: 3 months
FEF25-75% at 6 months
Pulmonary function will be measured by forced expiratory flow at 25 and 75% of the pulmonary volume (FEF25-75%) at six months.
Time frame: 6 months
FEV1/FVC ratio at baseline
FEV1/FVC ratio will be calculated at baseline. The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs.
Time frame: baseline
FEV1/FVC ratio at 3 months
FEV1/FVC ratio will be calculated at 3 months. The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs.
Time frame: 3 months
FEV1/FVC ratio at 6 months
FEV1/FVC ratio will be calculated at 6 months. The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second (FEV1) to the forced vital capacity (FVC) of the lungs.
Time frame: 6 months
FOT at baseline.
Forced Oscillation Technique (FOT) will be measured at baseline. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
Time frame: baseline
FOT at 3 months.
Forced Oscillation Technique (FOT) will be measured at 3 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
Time frame: 3 months
FOT at 6 months.
Forced Oscillation Technique (FOT) will be measured at 6 months. Forced Oscillation Technique (FOT) measures lung impedance during tidal breathing.
Time frame: 6 months
FACIT score at baseline and monthly on therapy
assess the effect of increasing the dose of IGRT on the patients' well-being by quantitating their fatigue level. Scores range from zero (no fatigue) to 52 (maximum fatigue/worse outcome).
Time frame: 6 months
PADQOL-16 at baseline and monthly on therapy
assess the effect of increasing the dose of IGRT on the patients' well-being by quantitating their quality of life. Scores range from zero (no impairment) to 32 (maximum impairment/worse outcome).
Time frame: 6 months
St. George's Respiratory Questionnaire at baseline and monthly on therapy
Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from zero (no impairment) to 100 (maximum impairment/worse outcome).
Time frame: 6 months
Plan to share: No
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Common Variable Immunodeficiency→
University of Alabama at Birmingham