Study of Octanorm Subcutaneous IG in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 Trial

The study is a prospective, open-label, non-controlled, single-arm, multicentre phase III
study. Patients will be followed from the time of completion of the SCGAM 01 trial until
octanorm becomes commercially available in the USA, until the sponsor decides to terminate
the trial, or until a patient's treatment duration of 2.5 years is reached (whichever occurs
first).

Inclusion Criteria:

1. Completion of the main study SCGAM 01, with good tolerance of octanorm (as determined
by the investigator).

2. For adult patients: freely given written informed consent. For patients below the
legal age of majority: freely given written informed consent from parents/legal
guardians and written informed assent from the child/adolescent in accordance with
local requirements.

3. For female patients of child-bearing potential, a negative result in a urine pregnancy
test conducted at the Screening visit.

4. Willingness to comply with all aspects of the protocol, including blood sampling, for
the duration of the study.

Exclusion Criteria:

1. Subject being without any IgG treatment for period greater than 5 weeks between the
last infusion of octanorm in the SCGAM 01 study and the first infusion of octanorm in
the SCGAM-03 study.

2. Administration of any immunoglobulin infusion other than octanorm between conclusion
of the SCGAM 01 study and the beginning of the present study. [Note: This exclusion
criterion does not apply to patients who complete the SCGAM 01 study before treatment
commences in the present study.]

3. Planned pregnancy during the course of the study.