Octagam 5% Versus Comparator Post Marketing Trial

June 7, 2019 updated by: Octapharma

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:

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

623

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Granada Hills, California, United States, 91344
        • Octapharma Research Site
      • Irvine, California, United States, 92697
        • Octapharma Research Site
      • Los Angeles, California, United States, 90025
        • Octapharma Research Site
      • Redlands, California, United States, 92373
        • Octapharma Research Site
    • Colorado
      • Centennial, Colorado, United States, 80112
        • Octapharma Research Site
    • Georgia
      • Roswell, Georgia, United States, 30076
        • Octapharma Research Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Octapharma Research Site
      • Springfield, Illinois, United States, 62701
        • Octapharma Research Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46815
        • Octapharma Research Site
    • Kansas
      • Wichita, Kansas, United States, 67201
        • Octapharma Research Site
    • Kentucky
      • Fort Mitchell, Kentucky, United States, 41017
        • Octapharma Research Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Octapharma Research Site
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Octapharma Research Site
      • Plymouth, Minnesota, United States, 55447
        • Octapharma Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Octapharma Research Site
    • New York
      • East Setauket, New York, United States, 11733
        • Octapharma Research Site
      • New York, New York, United States, 10012
        • Octapharma Research Site
      • New York, New York, United States, 10065
        • Octapharma Research Site
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Octapharma Research Site
      • Mayfield Heights, Ohio, United States, 44124
        • Octapharma Research Site
      • Toledo, Ohio, United States, 43617
        • Octapharma Research Site
    • Rhode Island
      • Pawtucket, Rhode Island, United States, 02860
        • Octapharma Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Octapharma Research Site
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Octapharma Research Site
    • Texas
      • Amarillo, Texas, United States, 79124
        • Octapharma Research Site
      • Dallas, Texas, United States, 75231
        • Octapharma Research Site
      • Irving, Texas, United States, 75014
        • Octapharma Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence Rate of Thromboembolytic events
Time Frame: 4 months
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Octapharma

Investigators

  • Principal Investigator: Wolfgang Frenzel, International Medical Monitor, Octapharma AG

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 21, 2013

Primary Completion (ACTUAL)

May 22, 2019

Study Completion (ACTUAL)

May 22, 2019

Study Registration Dates

First Submitted

May 9, 2013

First Submitted That Met QC Criteria

May 20, 2013

First Posted (ESTIMATE)

May 22, 2013

Study Record Updates

Last Update Posted (ACTUAL)

June 10, 2019

Last Update Submitted That Met QC Criteria

June 7, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAM5-28

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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