Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG (NCT06089122) | Clinical Trial Compass
UnknownPhase 3
Efficacy, Safety, and Pharmacokinetics of Shu Yang IVIG
50 participantsStarted 2024-04
Plain-language summary
To evaluate the safety, efficacy, and pharmacokinetic properties of Shu Yang intravenous immune globulin in patients with primary immune deficiency aged less than 60 years.
The main benefit of IVIG is to help the body fight against a large variety of infections generally associated with morbidity and mortality in patients with primary immunodeficiency diseases, particularly in CVID and XLA. In addition, a decrease in the number of infections, a reduction in medications and hospitalizations, and a better quality of life are expected.
Throughout treatment, approximately one-fourth of persons may experience a side effect. These are usually mild or bothersome but not dangerous. Very rarely, more serious side effects like allergic reactions or low blood counts (anemia) can occur. One of the most common side effects is headache. Other side effects include chills, fever, flushing, flu-like muscle pains or joint pains, feeling tired, nausea, vomiting, and rash. For the most part, these reactions typically happen with the first dose of IVIG or because change to a different brand of IVIG. All IVIG products have similar warnings and contraindications, such as the potential for renal failure, thrombotic events, aseptic meningitis, hemolysis, and anaphylactic reactions.
Who can participate
Age range6 Years – 60 Years
SexALL
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Inclusion criteria
✓. Written informed consent/assent.
✓. Male or female.
✓. Ages ≤ 60 years old and ≥ 06 years old.
✓. Diagnosis of Primary Immunodeficiency Disease (PID) with a reduction in antibody production due to:
✓. Receiving replacement therapy with intravenous immunoglobulin at 21- to 28-day intervals at 300-600 mg/kg/month for a minimum of 2 months before the start of the study;
✓. Absence of episodes of serious bacterial infections with previous use of an IV immunoglobulin for at least 3 months before screening;
✓. Negative pregnancy test (in female patients with childbearing potential); readiness to use reliable methods of contraception throughout the study period;
✓. Patients who participated in a clinical trial with another experimental IVIG may be enrolled if they have a potential benefit according to Res. CNS 251/1997;
Exclusion criteria
✕
What they're measuring
1
Primary Efficacy Objective (average of acute serious bacterial infections)
Timeframe: Between Visit 0 and Final Visit (through study completion, an average of 1 year)
. Known intolerance or hypersensitivity to immunoglobulins or components of the test article;
✕. Any contraindications to the use of immunoglobulins;
✕. Secondary immunodeficiency or conditions potentially causing secondary immunodeficiency such as chronic lymphoid leukemia, lymphoma, multiple myeloma, protein-losing enteropathies or nephropathies, and hypoalbuminemia;
✕. Clinically relevant changes in the safety exams are defined as: