Octagam 5% Versus Comparator Post Marketing Trial

Completed

Conditions studied: Primary Immune Deficiency Disorder

In brief

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.

Key facts

Study ID

NCT01859754

Run by

Octapharma

People needed

623

Starts

2013-05-21

Expected to finish

2019-05-22

Last updated by the study team

2019-06-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients aged 18 years.
• 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.
• 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.

You may not qualify if…

• Patients with a history of TEEs within the previous 24 months.
• Patients with a regular treatment frequency of more than once every 3 to 4 weeks.

Where it is running

• Octapharma Research Site — Granada Hills, California, United States
• Octapharma Research Site — Irvine, California, United States
• Octapharma Research Site — Los Angeles, California, United States
• Octapharma Research Site — Redlands, California, United States
• Octapharma Research Site — Centennial, Colorado, United States
• Octapharma Research Site — Roswell, Georgia, United States
• Octapharma Research Site — Chicago, Illinois, United States
• Octapharma Research Site — Springfield, Illinois, United States
• Octapharma Research Site — Fort Wayne, Indiana, United States
• Octapharma Research Site — Wichita, Kansas, United States
• Octapharma Research Site — Fort Mitchell, Kentucky, United States
• Octapharma Research Site — Farmington Hills, Michigan, United States
• Octapharma Research Site — Plymouth, Minnesota, United States
• Octapharma Research Site — Plymouth, Minnesota, United States
• Octapharma Research Site — Omaha, Nebraska, United States
• Octapharma Research Site — East Setauket, New York, United States
• Octapharma Research Site — New York, New York, United States
• Octapharma Research Site — New York, New York, United States
• Octapharma Research Site — Columbus, Ohio, United States
• Octapharma Research Site — Mayfield Heights, Ohio, United States
• Octapharma Research Site — Toledo, Ohio, United States
• Octapharma Research Site — Pawtucket, Rhode Island, United States
• Octapharma Research Site — Anderson, South Carolina, United States
• Octapharma Research Site — Nashville, Tennessee, United States
• Octapharma Research Site — Amarillo, Texas, United States

Full record on ClinicalTrials.gov

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