Status:
COMPLETED
Octagam 5% Versus Comparator Post Marketing Trial
Lead Sponsor:
Octapharma
Conditions:
Primary Immune Deficiency Disorder
Eligibility:
All Genders
18+ years
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.
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 fo...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 21 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 22 2019
Estimated Enrollment :
623 Patients enrolled
Trial Details
Trial ID
NCT01859754
Start Date
May 21 2013
End Date
May 22 2019
Last Update
June 10 2019
Active Locations (27)
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1
Octapharma Research Site
Granada Hills, California, United States, 91344
2
Octapharma Research Site
Irvine, California, United States, 92697
3
Octapharma Research Site
Los Angeles, California, United States, 90025
4
Octapharma Research Site
Redlands, California, United States, 92373