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Study on the Effect of Human Normal Immunoglobulin on Lung Disease in Patients with Primary Antibody Deficiency

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the progression of lung disease in individuals with Primary Antibody Deficiency (PAD). PAD is a condition where the body has difficulty producing enough antibodies to fight infections. The study includes various types of PAD, such as Common Variable Immunodeficiency (CVID), IgA deficiency, and Agammaglobulinemia. The treatment being tested involves the use of Human Normal Immunoglobulin, a substance derived from blood that helps boost the immune system. Several medications containing this substance are being used in the study, including Nanogam, HyQvia, Privigen, KIOVIG, Gammanorm, CUTAQUIG, GAMMAGARD S/D, Hizentra, Octagam, and Cuvitru.

The purpose of the study is to determine if higher doses of immunoglobulin can better protect against the progression of lung disease in people with PAD. Participants will receive either a standard dose or a higher dose of immunoglobulin. The study will monitor the health of participants over time, focusing on lung health and the number of respiratory infections they experience. The study will also look at the overall health costs and quality of life for participants.

Throughout the study, participants will have regular check-ups and may undergo tests such as CT scans to assess lung health. They will also keep a diary to track any respiratory symptoms and report any missed days from work or school due to illness. The study aims to provide valuable information on the effectiveness and cost-efficiency of different dosing strategies for managing PAD and its impact on lung health.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on age (8-60 years) and diagnosis of Primary Antibody Deficiency (PAD) or Common Variable Immunodeficiency Disorder (CVID).

    Participation requires written informed consent and current treatment with immunoglobulin replacement therapy.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline health status, including lung function and current immunoglobulin dosing (0.25 - 0.6 grams per kilogram every 3-4 weeks).

    CT scans are performed to measure airway disease and lung damage.

  3. Step 3

    Treatment phase

    Participants receive immunoglobulin therapy through either intravenous or subcutaneous routes. Medications include Nanogam, HyQvia, Privigen, KIOVIG, Gammanorm, CUTAQUIG, GAMMAGARD, Hizentra, Octagam, and Cuvitru.

    The dosage and frequency are adjusted to evaluate the protective value of higher immunoglobulin dosing on lung disease progression.

  4. Step 4

    Monitoring and data collection

    Participants maintain a daily diary to record pulmonary symptoms over two periods of two months each.

    Regular assessments include tracking respiratory infections, days missed from school or work, and quality of life using the EQ-5D questionnaire.

  5. Step 5

    Follow-up assessments

    CT scans are repeated at the end of the study to compare airway disease progression from the start of the trial.

    Immunological laboratory tests are conducted to evaluate changes in immune function.

  6. Step 6

    Completion of the study

    The study concludes with a final evaluation of health outcomes, including the difference in lung disease scores and overall health costs.

    Adverse events are monitored and reported throughout the study by an independent monitor.

Who can join the trial?

6 criteria

  • Age between 8 and 60 years.
  • Have a diagnosis of Primary Antibody Deficiency or Common Variable Immunodeficiency Disorder. These are conditions where the body has trouble making enough antibodies to fight infections.
  • Need for immunoglobulin replacement therapy or already receiving this therapy. This is a treatment that helps boost the immune system by providing antibodies.
  • Currently receiving IgG dosing between 0.25 and 0.6 grams per kilogram every 3 to 4 weeks. IgG is a type of antibody given to help the immune system.
  • Being treated and followed up for Primary Antibody Deficiency by a doctor at one of the participating centers.
  • Provide written informed consent, which means agreeing to participate in the study after understanding all the details.

Who cannot join the trial?

5 criteria

  • Patients who do not have a primary antibody deficiency. This means their immune system does not have the specific problems listed below.
  • Patients with other types of immune system problems not listed in the study.
  • Patients who are not in the specified age range for the study.
  • Patients who do not meet the gender requirements for the study.
  • Patients who are considered part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

Immunoglobulin Therapy This therapy involves the use of immunoglobulins, which are antibodies that help the immune system fight infections. In this trial, the focus is on using higher doses of immunoglobulins to see if they can protect the lungs and slow down the progression of lung disease in patients with primary antibody deficiency. The goal is to determine if this approach is effective and cost-efficient in managing the condition.

What is already known about the treatment

Immunoglobulin Therapy – This medication is administered intravenously or subcutaneously, depending on the specific needs of the patient. It is currently recognized in medical literature as a treatment for various primary antibody deficiencies, such as unclassified antibody deficiency, IgA deficiency, specific polysaccharide antibody deficiency, IgG subclass deficiency, common variable immunodeficiency, and agammaglobulinemia. The main therapeutic indication is to provide the necessary antibodies that the patient's body cannot produce, thereby helping to prevent infections and manage symptoms. At the molecular level, it works by supplying functional antibodies that can recognize and neutralize pathogens. It is classified pharmacologically as an immunoglobulin replacement therapy.

Investigated diseases

Primary Antibody Deficiency – This is a group of disorders where the immune system fails to produce enough antibodies, leading to increased susceptibility to infections. It includes several specific conditions such as unclassified antibody deficiency, IgA deficiency, specific polysaccharide antibody deficiency, IgG subclass deficiency, common variable immunodeficiency, and agammaglobulinemia. These conditions can vary in severity and symptoms, but generally involve frequent infections, particularly of the respiratory tract. Over time, individuals may experience chronic lung disease due to repeated infections. The progression of these conditions can lead to complications if not managed properly. Each subtype has its own unique characteristics, but they all share the common feature of impaired antibody production.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513124-41-00Protocol codeNL79088.041.21Estimated enrolment100 patientsSponsorUniversitair Medisch Centrum Utrecht

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