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Evaluation of Efficacy and Tolerability of Hizentra®

This study is currently recruiting participants.
Verified July 2012 by University of South Florida
Sponsor:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01354587
First received: March 18, 2011
Last updated: July 16, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention
Primary Immunodeficiency Disorders
 Drug: Hizentra

Study Type: Interventional
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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
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)
Arms Assigned Interventions
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.

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®.

  Eligibility

Ages Eligible for Study:   1 Year to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354587

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

Locations
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
Principal Investigator: John Sleasman, MD USF
  More Information

No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01354587     History of Changes
Other Study ID Numbers: Hizentra
Study First Received: March 18, 2011
Last Updated: July 16, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
immunodeficiency

Additional relevant MeSH terms:
Immunologic Deficiency Syndromes
Immune System Diseases

ClinicalTrials.gov processed this record on May 22, 2013