Pharmacokinetics, efficacy, tolerability and safety evaluation of the therapy with subcutaneous immunoglobulin in the treatment of hypo or agammaglobulinaemic patients. Open label phase II/III study - ND

• Conditions: Hypogammaglobulinaemia or agammaglobulinaemia; MedDRA version: 9.1Level: LLTClassification code 10060384; MedDRA version: 9.1Level: LLTClassification code 10001471

• Registration Number: EUCTR2010-020167-20-IT
• Lead Sponsor: KEDRIO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-11
• Last Update Posted: 10 July 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified