Primary immunodeficiency disease
Conditions
Interventions
Experimental group:Subcutaneous injection of human immunoglobulin (injection solution)
Sponsors
Children's Hospital of Chongqing Medical University
Eligibility
Sex/Gender
All
Age
2 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.At the time of signing the informed consent form, the participant must be >=2 years of age, with no gender restrictions; 2.Participants must be patients with primary immunodeficiency (PID) of the antibody deficiency type, including but not limited to common variable immunodeficiency (CVID) or X-linked agammaglobulinaemia (XLA), and must be able to provide relevant medical records. The investigator must determine that the patient requires long-term replacement therapy with human immunoglobulin; 3.Female participants of childbearing age have no plans to become pregnant during the trial (or the spouse of male participants has no plans to become pregnant), and participants agree to use effective contraception during the trial and for 90 days after the last dose; 4.Participants or their legal guardians fully understand and can comply with the trial protocol requirements, are willing to complete the study as planned, and voluntarily cooperate in providing biological samples for testing as required by the protocol; 5.The subject is able to understand the procedures and methods of this clinical trial, has provided informed consent after adequate explanation, and voluntarily participates in the trial. The informed consent form is signed by the subject or their guardian (for children under 8 years of age, informed consent is provided and the informed consent form is signed by the parents as guardians; for adolescents and children aged 8 years or older but under 18 years, informed consent is provided and the informed consent form is signed jointly by the subject and their parents as guardians).
Exclusion criteria
Exclusion criteria: 1.Body weight = 30 kg/m^2; 2. Known allergy to human immunoglobulin or other plasma proteins and/or blood products, particularly selective IgA deficiency with anti-IgA antibodies, including allergy to excipients of the investigational drug or history of hormone allergy; 3. Recurrent severe chronic bronchiectasis or chronic obstructive pulmonary disease; evidence of active severe bacterial infection (defined as bacteraemia/sepsis, bacterial meningitis, osteomyelitis/pyogenic arthritis, bacterial pneumonia, and visceral abscess) within 3 months prior to signing the informed consent form or during the screening period; 4.Participants with a history of epilepsy or migraine that is poorly controlled by medication; patients with uncontrolled hypertension (systolic blood pressure >=160 mmHg and/or diastolic blood pressure >=100 mmHg); 5. Haemoglobin = 1.5 times the upper limit of normal. Concurrent renal dysfunction or serum creatinine >= 2 times the upper limit of normal; creatinine clearance < 30 mL/min; 15.Patients with a history of drug abuse, substance abuse, or alcoholism; 16.Abortion or pregnancy termination within the past 3 months prior to signing the informed consent form; pregnant women and lactating women (currently breastfeeding or who have not yet weaned but are less than 1 year postpartum); 17. Patients with mental disorders or significant mental impairments; individuals with impaired capacity or cognitive ability due to other medical conditions, including those deemed by the investigator to have poor compliance, who cannot be evaluated for efficacy or are unlikely to comp
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Annualised incidence rate of serious bacterial infection (SBI) events; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence rate of all infection events per subject per year;Annual incidence rate of other infectious events per subject;Number of days of absence per year per subject due to infection and treatment (including missed school/work/daily activities);Number of days per year per subject treated with antibiotics for infection (including oral, parenteral, oral plus parenteral, prophylactic, and therapeutic);Number of days per year per subject hospitalised due to infection;Number of visits to the doctor per year per subject due to infection;Pharmacokinetics parameters; | — |
Countries
China
Contacts
Public ContactXiaodong Zhao
Children's Hospital of Chongqing Medical University
Outcome results
None listed