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NCT01859754 Clinical Trial

Octagam 5% Versus Comparator Post Marketing Trial

Primary Immune Deficiency Disorder Clinical Trial

Official title:
Postmarketing Requirement Non-Interventional 2-armed Study to Evaluate the Safety of Octagam® Immune Globulin Intravenous (Human) 5% Liquid Preparation, With a Special Emphasis on Monitoring, Analysis and Reporting of Thromboembolic Events

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01859754
Other study ID # GAM5-28
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 21, 2013
Est. completion date May 22, 2019

Study information
Verified date June 2019
Source Octapharma
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 623
Est. completion date May 22, 2019
Est. primary completion date May 22, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Octagam 5%
Intravenous immunoglobulin 5%
• Other marketed IVIG product
Any intravenous immunoglobulin marketed product approved for the treatment of PID

Locations
Country Name City State
United States Octapharma Research Site Amarillo Texas
United States Octapharma Research Site Anderson South Carolina
United States Octapharma Research Site Centennial Colorado
United States Octapharma Research Site Chicago Illinois
United States Octapharma Research Site Columbus Ohio
United States Octapharma Research Site Dallas Texas
United States Octapharma Research Site East Setauket New York
United States Octapharma Research Site Farmington Hills Michigan
United States Octapharma Research Site Fort Mitchell Kentucky
United States Octapharma Research Site Fort Wayne Indiana
United States Octapharma Research Site Granada Hills California
United States Octapharma Research Site Irvine California
United States Octapharma Research Site Irving Texas
United States Octapharma Research Site Los Angeles California
United States Octapharma Research Site Mayfield Heights Ohio
United States Octapharma Research Site Nashville Tennessee
United States Octapharma Research Site New York New York
United States Octapharma Research Site New York New York
United States Octapharma Research Site Omaha Nebraska
United States Octapharma Research Site Pawtucket Rhode Island
United States Octapharma Research Site Plymouth Minnesota
United States Octapharma Research Site Plymouth Minnesota
United States Octapharma Research Site Redlands California
United States Octapharma Research Site Roswell Georgia
United States Octapharma Research Site Springfield Illinois
United States Octapharma Research Site Toledo Ohio
United States Octapharma Research Site Wichita Kansas

Sponsors (1)
Lead Sponsor Collaborator
Octapharma

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence Rate of Thromboembolytic events 4 months
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