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Evaluation of Efficacy and Tolerability of Hizentra®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
University of South Florida

Study Description
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Brief Summary:
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®.

Condition or disease Intervention/treatment Phase
Primary Immunodeficiency Disorders Drug: Hizentra Not Applicable

Detailed Description:
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®.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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)
Study Start Date : October 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Hizentra
Compare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra
 Drug: Hizentra
Subjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects currently self-infusing with Vivaglobin® for at least six months prior to enrollment.
  • Diagnosis of antibody deficiency due to primary immune deficiency disease.
  • Stable serum IgG levels of > 550 mg/dl while on Vivaglobin® based on two determinations at least 8 weeks apart and obtained within 6 months of entry.
  • Willing to sign consent and follow study schedule.
  • 1 year to 75 years of age.

Exclusion Criteria:

  • Evidence of acute systemic illness or infection at within four weeks of screening or enrollment.
  • Any serious grade 3 or greater toxicity at screening.
  • History of bleeding or chronic skin disorders.
  • Selective IgA deficiency in absence of other antibody deficiencies
  • History of anaphylactic or severe systemic reaction to Vivaglobin.
  • Pregnant or breastfeeding females.
  • Use of systemic pre-medication prior to SCIG.
  • Protein losing enteropathy or nephritic syndrome.
  • Any condition that in the opinion of the investigator would interfere with the conduct of the study.
  • Subject or guardian unwilling to sign consent or adhere to study schedule.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Carla Duff, MSN 7275533515 cduff@health.usf.edu
Contact: Amy Baldwin 7275531258 abaldwin@health.usf.edu

Locations
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United States, Florida
University of South Florida Recruiting
St. Petersburg, Florida, United States, 33701
Contact: Carla Duff, MSN    727-553-3515    cduff@health.usf.edu   
Contact: Amy Baldwin    7275531258    abaldwin@health.usf.edu   
Principal Investigator: John Sleasman, MD         
Sub-Investigator: Carla Duff, MSN         
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: John Sleasman, MD University of South Florida
More Information
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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01354587    
Other Study ID Numbers: Hizentra
First Posted: May 17, 2011    Key Record Dates
Last Update Posted: July 17, 2012
Last Verified: July 2012
Keywords provided by University of South Florida:
immunodeficiency
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases