A multicentre, open, prospective study investigating clinical efficacy, safety, and pharmacokinetic properties of the human normal immunoglobulin for intravenous administration BT681 in patients with primary immunodeficiency disease (PID)
- Conditions
- primary immunodeficiency syndrome as congenital agammaglobulinaemia or hypogammaglobulinaemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndromeMedDRA version: 7.0Level: HLTClassification code 10036700
- Registration Number
- EUCTR2004-004465-15-DE
- Lead Sponsor
- Biotest AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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. <br>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.
- Secondary Outcome Measures
Name Time Method