Octagam 5% Versus Comparator Post Marketing Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Octapharma
Sponsor:
Information provided by (Responsible Party):
Octapharma
ClinicalTrials.gov Identifier:
NCT01859754
First received: May 9, 2013
Last updated: August 12, 2016
Last verified: August 2016
  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: December 2019
Estimated Primary Completion Date: December 2019 (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   (Adult, Senior)
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
Completed
Granada Hills, California, United States, 91344
Completed
Irvine, California, United States, 92697
Completed
Redlands, California, United States, 92373
United States, Colorado
Recruiting
Centennial, Colorado, United States, 80112
Contact: Michael Eppolito    201-604-1155      
United States, Minnesota
Completed
Plymouth, Minnesota, United States, 55446
United States, Nebraska
Octapharma Site Completed
Omaha, Nebraska, United States, 68124
United States, New York
Completed
East Setauket, New York, United States, 11733
United States, Ohio
Completed
Columbus, Ohio, United States, 43235
Completed
Toledo, Ohio, United States, 43617
United States, Rhode Island
Completed
Pawtucket, Rhode Island, United States, 02860
United States, Tennessee
Completed
Nashville, Tennessee, United States, 37203
United States, Texas
Recruiting
Dallas, Texas, United States, 75231
Contact: Michael Eppolito    201-604-1155      
Completed
Irving, Texas, United States
Sponsors and Collaborators
Octapharma
Investigators
Principal Investigator: Wolfgang Frenzel International Medical Monitor, Octapharma AG
  More Information

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01859754     History of Changes
Other Study ID Numbers: GAM5-28 
Study First Received: May 9, 2013
Last Updated: August 12, 2016
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
Gamma-Globulins
Rho(D) Immune Globulin
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 24, 2016