Octagam 5% Versus Comparator Post Marketing Trial

Condition(s) targeted: Primary Immune Deficiency Disorder

Intervention: Octagam 5% (Biological); Other marketed IVIG product (Biological)

Phase: N/A

Status: Recruiting

Sponsored by: Octapharma

Official(s) and/or principal investigator(s):
Wolfgang Frenzel, Principal Investigator, Affiliation: International Medical Monitor, Octapharma AG

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.

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 design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Incidence Rate of Thromboembolytic events

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Allergy and Asthma Relief Experts, Granada Hills, California 91344, United States; Recruiting
Araceli Vasquez, MD, Ext: 112, Email: araceli@asthmadoc.com
Jacob Offenberger, MD, Principal Investigator

University of California Irvine, Irvine, California 92697, United States; Active, not recruiting

Beaver Medical Group, L.P., Redlands, California 92373, United States; Recruiting
Martha Steinharter, Email: martha.steinharter@gmail.com
Moshen Mabudian, MD, Principal Investigator

Immunoe Research, Centennial, Colorado 80112, United States; Recruiting
Laura Ullate, Email: LUllate@immunoe.com
Isaac Melamed, MD, Principal Investigator

Asthma and Allergy Associates of Omaha, Omaha, Nebraska 68124, United States; Recruiting
Ai Lan Kobayashi, MD, Email: midlandspeds@gmail.com
Roger Kobayashi, MD, Principal Investigator

North Shore Hematology Oncology Associates, East Setauket, New York 11733, United States; Recruiting
George Calcances, RN, Email: georgenicholas26@aol.com
Jeffrey Vacirca, MD, Principal Investigator

Optimed Research Ltd, Columbus, Ohio 43235, United States; Recruiting
Ann Urbank, NP, Ext: 109, Email: ann@optimed.us.com
Donald McNeil, MD, Principal Investigator

The Toledo Institute of Clinical Research, Inc., Toledo, Ohio 43617, United States; Recruiting
Patricia Bak, Email: coral_expressions@yahoo.com
Syed Rehman, MD, Principal Investigator

Memorial Hospital of Rhode Island, Pawtucket, Rhode Island 02860, United States; Recruiting
Patti Wingate, Email: patti_wingate@mhri.org
Iole Ribizzi-Akhtar, MD, Principal Investigator

BreatheAmerica, Inc., Nashville, Tennessee 37203, United States; Recruiting
John Gomillion, Email: jgomillion@breatheamerica.com
David Hagaman, MD, Principal Investigator

AARA Research Center, Dallas, Texas 75231, United States; Recruiting
Julie Tucker, Email: jtucker@aararesearch.com
William Lumry, MD, Principal Investigator

Starting date: May 2013
Last updated: June 5, 2015