Octagam 5% Versus Comparator Post Marketing Trial

Sponsor

Octapharma (Industry)

Overall Status

Completed

CT.gov ID

NCT01859754

Collaborator

(none)

623

Enrollment

Locations

Actual Duration (Months)

23.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Actual Enrollment :

623 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

Actual Study Start Date :

May 21, 2013

Actual Primary Completion Date :

May 22, 2019

Actual Study Completion Date :

May 22, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Incidence Rate of Thromboembolytic events [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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 Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
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
5	Octapharma Research Site	Centennial	Colorado	United States	80112
6	Octapharma Research Site	Roswell	Georgia	United States	30076
7	Octapharma Research Site	Chicago	Illinois	United States	60612
8	Octapharma Research Site	Springfield	Illinois	United States	62701
9	Octapharma Research Site	Fort Wayne	Indiana	United States	46815
10	Octapharma Research Site	Wichita	Kansas	United States	67201
11	Octapharma Research Site	Fort Mitchell	Kentucky	United States	41017
12	Octapharma Research Site	Farmington Hills	Michigan	United States	48334
13	Octapharma Research Site	Plymouth	Minnesota	United States	55446
14	Octapharma Research Site	Plymouth	Minnesota	United States	55447
15	Octapharma Research Site	Omaha	Nebraska	United States	68124
16	Octapharma Research Site	East Setauket	New York	United States	11733
17	Octapharma Research Site	New York	New York	United States	10012
18	Octapharma Research Site	New York	New York	United States	10065
19	Octapharma Research Site	Columbus	Ohio	United States	43235
20	Octapharma Research Site	Mayfield Heights	Ohio	United States	44124
21	Octapharma Research Site	Toledo	Ohio	United States	43617
22	Octapharma Research Site	Pawtucket	Rhode Island	United States	02860
23	Octapharma Research Site	Anderson	South Carolina	United States	29621
24	Octapharma Research Site	Nashville	Tennessee	United States	37203
25	Octapharma Research Site	Amarillo	Texas	United States	79124
26	Octapharma Research Site	Dallas	Texas	United States	75231
27	Octapharma Research Site	Irving	Texas	United States	75014