Study to Evaluate the Efficacy, Tolerability and Safety of Octanorm in Patients With Primary Immunodeficiency Diseases

Inclusion Criteria

• Age of ≥18 years and ≤70 years.
• Confirmed diagnosis of PI requiring immunoglobulin replacement therapy due to hypogammaglobulinaemia or agammaglobulinaemia. The type of PI should be recorded.
• Patients with at least 4 infusions on regular treatment with any Intravenous Immunoglobulin (IVIG) prior to entering the study. Constant IVIG dose between 200 and 800 mg/kg body weight (the individual doses of the last 4 infusions should not vary by more than ±25% of the mean dose for the last 4 infusions).
• Availability of at least 2 IgG trough levels with an IgG level of ≥5.0 g/L from the period of the last 4 IVIG infusions.
• Negative result on a pregnancy test (Human Chorionic Gonadotrophin [HCG]-based assay in urine) for women of childbearing potential and use of a reliable method of contraception for the duration of the study. Women of non-childbearing potential must be post-menopausal (amenorrhoeic for at least 12 months) or surgically sterile.

Examples for medically acceptable methods of birth control for this study include:

• Oral, implantable, transdermal or injectable contraceptives
• Intrauterine device
• Condoms; diaphragm or vaginal ring with spermicidal jellies or cream
• Sexual abstinence
• Vasectomised partner
• Patient must freely give written informed consent.
• Willingness to comply with all aspects of the protocol, including blood sampling, for the duration of the study.

Exclusion Criteria

• Acute infection requiring intravenous (IV) antibiotic treatment within 2 weeks prior to and during the screening period.
• Known history of adverse reactions to Immunoglobulin A in other products.
• Patients with body mass index >40 kg/m2
• Exposure to blood or any blood product or plasma derivatives, other than IVIG treatment of PI, within the past 3 months prior to first infusion of octanorm.
• Ongoing history of hypersensitivity or persistent reactions to blood or plasma derived products, or any component of the investigational medicinal product (IMP) (such as Polysorbate 80).
• History of malignancies of lymphoid cells and immunodeficiency with lymphoma.
• Severe liver function impairment (ALAT 3 times above upper limit of normal).
• Known protein-losing enteropathies or proteinuria.
• Presence of renal function impairment (creatinine >120 µM/L or creatinine >1.35 mg/dL), or predisposition for acute renal failure (e.g., any degree of pre-existing renal insufficiency or routine treatment with known nephritic drugs).
• Treatment with enteral or parenteral steroids for ≥30 days or when given intermittently or as bolus, at daily doses ≥0.15 mg/kg. Inhaled corticosteroids are allowed.
• Patients with chronic obstructive pulmonary disease (COPD) stage Global Initiative for Chronic Obstructive Lung Disease (GOLD) III or IV.
• Treatment with immunosuppressive drugs.
• Live viral vaccination (such as measles, rubella, mumps and varicella) within the last 2 months prior to first infusion of octanorm.
• Treatment with any IMP within 3 months prior to first infusion of octanorm.
• Presence of any condition that is likely to interfere with the evaluation of study medication or satisfactory conduct of the trial.
• Known or suspected to abuse alcohol, drugs, psychotropic agents or other chemicals within the past 12 months prior to first infusion of octanorm.
• Known or suspected human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (HBV) infection.
• Pregnant or nursing women; planned pregnancy during course of the study