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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 October 2019
• Main ID: NCT02627300
• Date of registration: 03/12/2015
• Prospective Registration: Yes
• Primary sponsor: Octapharma
• Public title: Study of Octanorm Subcutaneous IG in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 Trial
• Scientific title: Clinical Phase III Study to Monitor the Safety, Tolerability and Efficacy of Subcutaneous Human Immunoglobulin (Octanorm) in Patients With Primary Immunodeficiency Diseases Who Have Completed the SCGAM-01 Trial
• Date of first enrolment: March 2016
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02627300
• Study type: Interventional
• Study design: Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Canada, United States

Contacts

• Name: Wolfgang Frenzel
• Affiliation: International Medical Monitor

Key inclusion & exclusion criteria

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.



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Primary Immunodeficiency Disease

Intervention(s)

Drug: Octanorm 16.5%

Primary Outcome(s)

Local injection-site reactions [Time Frame: through study completion, an average of 3 years]

Measurement of trough total IgG levels; monitoring for infectious diseases. Occurrence of serious bacterial infections (SBIs) [Time Frame: through study completion, an average of 3 years]

Vital signs (blood pressure, pulse, body temperature, respiratory rate) [Time Frame: through study completion, an average of 3 years]

Occurrence of all treatment-emergent adverse events (TEAEs) [Time Frame: through study completion, an average of 3 years]

Laboratory parameters (haematology, clinical chemistry, basic urinalysis) [Time Frame: through study completion, an average of 3 years]

Child Health Questionnaire-Parent Form (CHQ-PF50); SF-36 Health Survey [Time Frame: through study completion, an average of 3 years]

TEAEs by speed of infusion [Time Frame: through study completion, an average of 3 years]

Occurrence of temporally associated TEAEs [Time Frame: through study completion, an average of 3 years]

Secondary ID(s)

SCGAM-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors