Hypogammaglobulinaemia or agammaglobulinaemia MedDRA version: 9.1 Level: LLT Classification code 10060384 MedDRA version: 9.1 Level: LLT Classification code 10001471
Conditions
Interventions
Product Name: Kedrion SCIg 16%
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Immunoglobulins, normal human, for extravascular adm.
Concentration unit: g/l gram(s)/litre
Concentratio
Sponsors
KEDRION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with hypogammaglobulinaemia or agammaglobulinaemia; 2. Male or female with age from 2 to less than 61 years; 3. Patients already on treatment with immunoglobulin preparation (intravenous or subcutaneous) for at least 6 months, with documented IgG trough levels > 500 mg/dl; 4. Written informed consent and authorization for treatment of personal data Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Patient not previously treated with immunoglobulin; 2. Patient is positive for HIV, HCV, or HBV; 3. Pregnant or breastfeeding women or women of childbearing potential not using adequate contraception; 4. Patient presents severe systemic diseases or associated conditions contraindicating the use of immunoglobulin (thrombocytopenia gravis, coagulation disorders, allergic reactions to Ig) or record of severe adverse reactions to blood or blood derivatives; 5. Acute bacterial infections that required treatment with intravenous antibiotics in the previous 1 week; 6. Treatment with immunosuppressive drugs in the previous 3 weeks; 7. Allogeneic bone marrow transplantation during the last year before inclusion; 8. Nephrotic syndrome characterized by proteinuria = 3.5 g/24h, serum protein levels < 60 g/l or serum albumin levels < 30 g/l; 9. Chronic renal failure or creatinine clearance < 80 ml/min according to Cockroft formula; 10. History of heart failure (NYHA III/IV), cardiomyopathy, congestive heart failure, severe hypertension, cancer of lymphoid cells, hypoalbuminemia, protein-dispersive enteropathy; 11. Associated condition of chronic broncho-pneumopathy; 12. Presence of any conditions which, in the investigator’s judgment, may interfere with study objective evaluation; 13. Subject participated in another clinical study during the month prior to study start date (the subject received other study drugs during the last 30 days)or refused to sign the written informed consent required for participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of pharmacokinetics, efficacy, and safety of Kedrion 16% subcutaneous immunoglobulin preparation (Kedrion SCIg);Secondary Objective: Not applicable;Primary end point(s): Number of serious acute bacterial infections (bacteraemia or sepsis, bacterial meningitis, osteomyelitis, septic arthritis, bacterial pneumonia, visceral abscess). Limits of acceptability: 1 serious infection/patient/year | — |
Countries
Italy
Outcome results
None listed