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)

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2004-004465-15-DE
• Date of registration: 04/02/2005
• Prospective Registration: Yes
• Primary sponsor: Biotest AG
• Public title: 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)
• Scientific title: 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)
• Date of first enrolment: 05/04/2005
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2004-004465-15
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no

Countries of recruitment

Germany, Hungary

Key inclusion & exclusion 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:
- 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Intervention(s)

Product Name: Intratect
Product Code: BT681
Pharmaceutical Form: Solution for infusion
Current Sponsor code: BT681 (Intratect)
Other descriptive name: human normal immunoglobulin (IVIg)
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

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.

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 Objective: Comparison of IgG trough levels to previous standard IVIG treatment

Secondary ID(s)

Study No. 957