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Octagam 5% Versus Comparator Post Marketing Trial

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ClinicalTrials.gov Identifier: NCT01859754
Recruitment Status : Recruiting
First Posted : May 22, 2013
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Octapharma

Brief 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.


Condition or disease Intervention/treatment
Primary Immune Deficiency Disorder Biological: Octagam 5% Biological: Other marketed IVIG product

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
Estimated Enrollment : 500 participants
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
Study Start Date : May 2013
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : May 2019


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




Primary Outcome Measures :
  1. Incidence Rate of Thromboembolytic events [ Time Frame: 4 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01859754


Contacts
Contact: Mikaela Grupp 866-337-1868 ctgov@clinicalresearchmgt.com

  Show 26 Study Locations
Sponsors and Collaborators
Octapharma
Investigators
Principal Investigator: Wolfgang Frenzel International Medical Monitor, Octapharma AG

Responsible Party: Octapharma
ClinicalTrials.gov Identifier: NCT01859754     History of Changes
Other Study ID Numbers: GAM5-28
First Posted: May 22, 2013    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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