Clinical trial NCT01859754: Octagam 5% Versus Comparator Post Marketing 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Immune Deficiency Disorder
Keywords: Primary Immune Deficiency Syndrome
Primary immunodeficiency Disease (PIDD)
PID
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2013-05-22
Enrollment: 623
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over 18 years old with Primary Immune Deficiency Syndrome PID receiving marketed IVIG as treatment

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Rate of Thromboembolytic events
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Granada Hills
country: United States
facility: Octapharma Research Site
state: California
city: Irvine
country: United States
facility: Octapharma Research Site
state: California
city: Los Angeles
country: United States
facility: Octapharma Research Site
state: California
city: Redlands
country: United States
facility: Octapharma Research Site
state: California
city: Centennial
country: United States
facility: Octapharma Research Site
state: Colorado
city: Roswell
country: United States
facility: Octapharma Research Site
state: Georgia
city: Chicago
country: United States
facility: Octapharma Research Site
state: Illinois
city: Springfield
country: United States
facility: Octapharma Research Site
state: Illinois
city: Fort Wayne
country: United States
facility: Octapharma Research Site
state: Indiana
city: Wichita
country: United States
facility: Octapharma Research Site
state: Kansas
city: Fort Mitchell
country: United States
facility: Octapharma Research Site
state: Kentucky
city: Farmington Hills
country: United States
facility: Octapharma Research Site
state: Michigan
city: Plymouth
country: United States
facility: Octapharma Research Site
state: Minnesota
city: Plymouth
country: United States
facility: Octapharma Research Site
state: Minnesota
city: Omaha
country: United States
facility: Octapharma Research Site
state: Nebraska
city: East Setauket
country: United States
facility: Octapharma Research Site
state: New York
city: New York
country: United States
facility: Octapharma Research Site
state: New York
city: New York
country: United States
facility: Octapharma Research Site
state: New York
city: Columbus
country: United States
facility: Octapharma Research Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Octapharma Research Site
state: Ohio
city: Toledo
country: United States
facility: Octapharma Research Site
state: Ohio
city: Pawtucket
country: United States
facility: Octapharma Research Site
state: Rhode Island
city: Anderson
country: United States
facility: Octapharma Research Site
state: South Carolina
city: Nashville
country: United States
facility: Octapharma Research Site
state: Tennessee
city: Amarillo
country: United States
facility: Octapharma Research Site
state: Texas
city: Dallas
country: United States
facility: Octapharma Research Site
state: Texas
city: Irving
country: United States
facility: Octapharma Research Site
state: Texas
Study officials:
affiliation: International Medical Monitor, Octapharma AG
name: Wolfgang Frenzel
role: PRINCIPAL_INVESTIGATOR
References: