primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome MedDRA version: 7.0 Level: HLT Classification code 10036700
Conditions
Interventions
Product Name: Intratect
Product Code: BT681
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BT681 (Intratect)
Other descriptive name: human normal immunoglobulin (IVIg)
Concentration
Sponsors
Biotest AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome - written informed consent (signed by patient and/or legal guardian if applicable) - established replacement therapy with a single IVIG reference preparation including documentation of IgG trough levels during the previous 6 months - constant IVIG dose that had not changed by ±50% of the mean dose for at least 3 months prior to study entry and had maintained IgG trough levels of >= 6 g/l - male or female patients (age 6 - 50 years) 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: - pregnancy or unreliable contraceptive measures or lactation period (women only) - known intolerance to immunoglobulins or comparable substances (e.g. vaccination reaction) - known intolerance to proteins of human origin - participation in another clinical trial within 90 days before entering the study or during the study and/or previous participation in this study - inability or lacking motivation to participate in the study - selective, absolute IgA deficiency - positive diagnostics of hepatitis B and hepatitis C - positive HIV test - acquired medical condition known to cause secondary immune deficiency such as CLL, lymphoma, multiple myeloma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Main objective of this phase IIIa/IV study is to demonstrate efficacy, safety, and pharmacokinetic properties of the new human normal intravenous immunoglobulin preparation Intratect®/BT681 in patients with primary immunodeficiency syndromes (PID) with hypo- or agammaglobulinemia. So far, 17 PID patients had been treated in a clinical study with Intratect®/BT681 for a 6months period (Scheuplein et al, 2002). In the present study, 50 patients are planned to be enrolled for a treatment period of 48 weeks in order to achieve adequate statistical power and to exclude a bias on the efficacy data by seasonal influences, respectively.;Secondary Objective: Comparison of IgG trough levels to previous standard IVIG treatment;Primary end point(s): Number of acute serious bacterial infections per subject per year including bacterial pneumonia, bacteremia/sepsis, osteomyelitis/septic arthritis, visceral abscesses, and bacterial meningitis. | — |
Countries
Germany, Hungary
Outcome results
None listed