Evaluation of Efficacy and Tolerability of Hizentra®
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|ClinicalTrials.gov Identifier: NCT01354587|
Recruitment Status : Unknown
Verified July 2012 by University of South Florida.
Recruitment status was: Recruiting
First Posted : May 17, 2011
Last Update Posted : July 17, 2012
|Condition or disease||Intervention/treatment||Phase|
|Primary Immunodeficiency Disorders||Drug: Hizentra||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product)|
|Study Start Date :||October 2010|
|Estimated Primary Completion Date :||August 2012|
|Estimated Study Completion Date :||August 2012|
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.
- To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®. [ Time Frame: 32 weeks ]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 ]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 ]IgG levels are obtained at each visit.
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): NCT01354587
|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||University of South Florida|