Evaluation of Efficacy and Tolerability of Hizentra®
The purpose of this study is to measure the changes in the Treatment Satisfaction Questionnaire for Medication in the areas of effectiveness, side effects, and convenience of administration of each medication in Primary Immunodeficiency Disorder (PIDD) subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product)|
- To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®. [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]Subjects complete the TSQM at each study visit
- To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®. [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]Study subjects complete a weekly infusion diary that is collected at each study visit.
- To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®. [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]IgG levels are obtained at each visit.
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||August 2012|
|Estimated Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Hizentra
Compare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra
Subjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks.
This trial will evaluate subjects with Primary Immunodeficiency Disorder (PIDD) who are currently self-infusing Vivaglobin therapy for at least six months prior to changing to Hizentra® therapy. Following screening and enrollment, subjects will continue to self-infuse Vivaglobin® for seven infusions and then be converted to subcutaneous Hizentra® treatment which they will continue for the next 6 months. The study will determine if Hizentra® provides improved subject satisfaction by Treatment Satisfaction Questionnaire for Medication. Diaries related to the local site reactions, the number of infusion sites per subject/per dose, volume of Hizentra® per site, duration of infusions, systemic side effects of the new medication and dose on IgG levels and antibody titers, and local site reactions with Hizentra®.
|Contact: Carla Duff, MSNfirstname.lastname@example.org|
|Contact: Amy Baldwinemail@example.com|
|United States, Florida|
|University of South Florida||Recruiting|
|St. Petersburg, Florida, United States, 33701|
|Contact: Carla Duff, MSN 727-553-3515 firstname.lastname@example.org|
|Contact: Amy Baldwin 7275531258 email@example.com|
|Principal Investigator: John Sleasman, MD|
|Sub-Investigator: Carla Duff, MSN|
|Principal Investigator:||John Sleasman, MD||USF|