Octagam 5% Versus Comparator Post Marketing Trial
Information source: Octapharma
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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.
Eligibility
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.
Locations and Contacts
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
Additional Information
Starting date: May 2013
Last updated: June 5, 2015
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