Octagam 5% Versus Comparator Post Marketing Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Octapharma
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01859754
First received: May 9, 2013
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Primary Immune Deficiency Disorder
Biological: Octagam 5%
Biological: Other marketed IVIG product

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Octapharma:

Primary Outcome Measures:
  • Incidence Rate of Thromboembolytic events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 2500
Study Start Date: May 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Biological: Octagam 5%
Intravenous immunoglobulin 5%
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.
Biological: Other marketed IVIG product
Any intravenous immunoglobulin marketed product approved for the treatment of PID

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients over 18 years old with Primary Immune Deficiency Syndrome PID receiving marketed IVIG as treatment

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01859754

Locations
United States, California
Allergy and Asthma Relief Experts Recruiting
Granada Hills, California, United States, 91344
Contact: Araceli Vasquez, MD    818-366-8112 ext 112    araceli@asthmadoc.com   
Principal Investigator: Jacob Offenberger, MD         
University of California Irvine Recruiting
Irvine, California, United States, 92697
Contact: Maritza Clawges    949-824-2032    mclawges@uci.edu   
Principal Investigator: Sudhir Gupta, MD         
United States, Colorado
Immunoe Research Recruiting
Centennial, Colorado, United States, 80112
Contact: Laura Ullate       LUllate@immunoe.com   
Principal Investigator: Isaac Melamed, MD         
United States, Nebraska
Asthma and Allergy Associates of Omaha Recruiting
Omaha, Nebraska, United States, 68124
Contact: Ai Lan Kobayashi, MD       midlandspeds@gmail.com   
Principal Investigator: Roger Kobayashi, MD         
United States, New York
North Shore Hematology Oncology Associates Recruiting
East Setauket, New York, United States, 11733
Contact: George Calcances, RN    631-751-3000    georgenicholas26@aol.com   
Principal Investigator: Jeffrey Vacirca, MD         
United States, Ohio
Optimed Research Ltd Recruiting
Columbus, Ohio, United States, 43235
Contact: Ann Urbank, NP    614-430-8022 ext 109    ann@optimed.us.com   
Principal Investigator: Donald McNeil, MD         
The Toledo Institute of Clinical Research, Inc. Recruiting
Toledo, Ohio, United States, 43617
Contact: Patricia Bak    419-843-8815    coral_expressions@yahoo.com   
Principal Investigator: Syed Rehman, MD         
United States, Rhode Island
Memorial Hospital of Rhode Island Recruiting
Pawtucket, Rhode Island, United States, 02860
Contact: Patti Wingate    401-729-2225    patti_wingate@mhri.org   
Principal Investigator: Iole Ribizzi-Akhtar, MD         
United States, Tennessee
BreatheAmerica, Inc. Recruiting
Nashville, Tennessee, United States, 37203
Contact: John Gomillion    615-665-7130    jgomillion@breatheamerica.com   
Principal Investigator: David Hagaman, MD         
United States, Texas
AARA Research Center Recruiting
Dallas, Texas, United States, 75231
Contact: Julie Tucker    214-365-0365    jtucker@aararesearch.com   
Principal Investigator: William Lumry, MD         
Sponsors and Collaborators
Octapharma
Investigators
Principal Investigator: Wolfgang Frenzel International Medical Monitor, Octapharma AG
  More Information

No publications provided

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01859754     History of Changes
Other Study ID Numbers: GAM5-28
Study First Received: May 9, 2013
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Octapharma:
Primary Immune Deficiency Syndrome
Primary immunodeficiency Disease (PIDD)
PID

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 19, 2014