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

Primary Immunodeficiency Disease Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627300
• Other study ID #: SCGAM-03
• Status: Completed
• Phase: Phase 3
• Start date: March 2016
• Est. completion date: September 5, 2019

Study information

• Verified date: September 2019
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 5, 2019
• Est. primary completion date: September 5, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immunodeficiency Disease

Intervention

Drug:
• Octanorm 16.5%

Locations

Country	Name	City	State
United States	Octapharma Research Site	Centennial	Colorado
United States	Octapharma Research Site	Frisco	Texas
United States	Octapharma Research Site	Irvine	California
United States	Octapharma Research Site	Papillion	Nebraska
United States	Octapharma Research Site	San Diego	California
United States	Octapharma Research Site	Toledo	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of all treatment-emergent adverse events (TEAEs)	Safety	through study completion, an average of 3 years
Primary	Occurrence of temporally associated TEAEs	Safety	through study completion, an average of 3 years
Primary	TEAEs by speed of infusion	Safety	through study completion, an average of 3 years
Primary	Local injection-site reactions	Safety	through study completion, an average of 3 years
Primary	Vital signs (blood pressure, pulse, body temperature, respiratory rate)	Safety	through study completion, an average of 3 years
Primary	Laboratory parameters (haematology, clinical chemistry, basic urinalysis)	Safety	through study completion, an average of 3 years
Primary	Measurement of trough total IgG levels; monitoring for infectious diseases. Occurrence of serious bacterial infections (SBIs)	Efficacy	through study completion, an average of 3 years
Primary	Child Health Questionnaire-Parent Form (CHQ-PF50); SF-36 Health Survey	Quality of Life	through study completion, an average of 3 years