Octagam 5% Versus Comparator Post Marketing Trial

Completed

• Conditions: Primary Immune Deficiency Disorder
• Interventions: Biological: Other marketed IVIG product; Biological: Octagam 5%

• Registration Number: NCT01859754
• Lead Sponsor: Octapharma

Brief Summary

Study Design:

This is a 2 arm non-interventional trial that will compare the occurrence of adverse drug reactions between Octagam 5% and other marketed IVIG infusion treatments.

Detailed Description

This Post Marketing Study is a prospective, 2-armed, multicenter, non-interventional study. Patients will either be administered the brand of IGIV therapy ordered by their prescribing physician, or for patients issued unspecified or generic prescriptions of IGIV therapy, octagam® 5% or another brand of IGIV therapy will be provided by the Investigator according to federal, state and local regulations and good clinical practice (GCP) guidelines.

The primary objective is to assess and evaluate the safety profile of octagam® 5% during or after administration under routine clinical use for all labeled indications, with a special emphasis on the occurrence of TEEs. The incidence of TEEs in patients receiving octagam® 5% will be compared with the incidence rate in a matching concurrent control group of patients receiving other IGIVs for routine clinical use.

Study Timeline

• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-20
• Study Start: 2013-05-21
• Study First Posted: 2013-05-22
• Primary Completion: 2019-05-22
• Study Completion: 2019-05-22
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-07
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 623

Inclusion Criteria

1. Male and female patients aged 18 years.
2. Patients with confirmed diagnosis of Primary Humoral Immunodeficiency (PI) as stated by the World Health Organization and requiring immunoglobulinreplacement therapy due to hypogammaglobulinemia or agammaglobulinemia.
3. Patients on regular treatment (every 3 to 4 weeks) with low dose IGIV (1 g/kg) for a period of at least 6 months without changing the brand.

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Exclusion Criteria

1. Patients with a history of TEEs within the previous 24 months.
2. Patients with a regular treatment frequency of more than once every 3 to 4 weeks.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Other marketed IVIG product	Other marketed IVIG product	Primary Immune Deficiency Syndrome patients receiving marketed IVIG product other than Octagam 5% by infusion as treatment for at least 6 months.
Octagam 5%	Octagam 5%	Primary Immune Deficiency Syndrome patients receiving Octagam 5% by infusion who have been treated with a marketed IVIG product for at least 6 months.

Primary Outcome Measures

Name	Time	Method
Incidence Rate of Thromboembolytic events	4 months

Trial Locations

Locations (1)

Octapharma Research Site; 🇺🇸 Irving, Texas, United States