Study to evaluate the efficacy, metabolism and safety of human immuneglobulin in patients with primary immunodeficiency diseases

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 23

Inclusion Criteria

1.Age of >= 18 years and <= 75 years.
2.Primary immunodeficiency syndromes with significant component hypogamma-globulinaemia or antibody deficiency.
3.Previously treated with a commercial IVIG
a) approximately every 21–28 days for at least 6 infusion intervals b) at a constant dose between 200 and 800 mg/kg body weight (+/- 20% of the mean dose for the last 6 infusions).
4.Availability of the IgG trough levels of the 2 previous infusions before enrolment, and maintenance of more than 5.0 g/L in the trough levels of these 2 infusions.
5.Negative result on a pregnancy test for women of childbearing potential and use of a reliable method of contraception for the duration of the study.
6.Freely given written informed consent.
7.Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.
Are the trial subjects under 18? no
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 22
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1

Exclusion Criteria

8.Acute infection requiring intravenous antibiotic treatment within 2 weeks prior to and during the screening period.
9.Known history of adverse reactions to IgA in other products.
10.Exposure to blood or any blood product or derivative, other than commercially available IVIG, within the past 3 months prior to enrolment.
11.Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational product.
12.Requirement of any routine premedication for IVIG infusion.
13.History of congenital impairment of pulmonary function.
14.Severe liver function impairment
15.Presence of renal function impairment, or predisposition for acute renal failure.
16.History of autoimmune haemolytic anaemia.
17.History of diabetes mellitus.
18.Congestive heart failure NYHA class III or IV.
19.Non-controlled arterial hypertension.
20.History of deep vein thrombosis or thrombotic complications of IVIG therapy.
21.Known HIV, HCV, or HBV infection.
22.Presence of any clinically relevant disease or unstable condition at screening, other than PID, which in the opinion of the Investigator could interfere with the conduct of the study.
23.Treatment with steroids , immunosuppressive or immunomodulatory drugs.
24.Planned vaccination during the study period except for killed” influenza vaccines (incl. H1N1).
25.Participating in another clinical trial or planned participation in another trial for the duration of this study.
26.Treatment with any investigational agent within 3 months prior to enrolment.
27.Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to enrolment.
28.Pregnant or nursing women.
29.Unable or unwilling to comply with the study protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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