Back to resultsEvaluation of Efficacy and Tolerability of Hizentra®
Primary Purpose
Primary Immunodeficiency Disorders
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hizentra
Sponsored by
About this trial
This is an interventional treatment trial for Primary Immunodeficiency Disorders focused on measuring immunodeficiency
Eligibility 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.
Sites / Locations
- University of South FloridaRecruiting
Arms of the Study
Arm 1
Arm Type
Active Comparator
Arm Label
Hizentra
Arm Description
Compare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra
Outcomes
Primary Outcome Measures
To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.
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®.
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®.
IgG levels are obtained at each visit.
Full Information
NCT ID
NCT01354587
First Posted
March 18, 2011
Last Updated
July 16, 2012
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT01354587
Brief Title
Evaluation of Efficacy and Tolerability of Hizentra®
Official Title
Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
August 2012 (Anticipated)
Study Completion Date
August 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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®.
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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immunodeficiency Disorders
Keywords
immunodeficiency
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Hizentra
Arm Type
Active Comparator
Arm Description
Compare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra
Intervention Type
Drug
Intervention Name(s)
Hizentra
Intervention Description
Subjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks.
Primary Outcome Measure Information:
Title
To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.
Description
Subjects complete the TSQM at each study visit
Time Frame
32 weeks
Secondary Outcome Measure Information:
Title
To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.
Description
Study subjects complete a weekly infusion diary that is collected at each study visit.
Time Frame
32 weeks
Title
To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.
Description
IgG levels are obtained at each visit.
Time Frame
32 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carla Duff, MSN
Phone
7275533515
Email
cduff@health.usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Amy Baldwin
Phone
7275531258
Email
abaldwin@health.usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sleasman, MD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carla Duff, MSN
Phone
727-553-3515
Email
cduff@health.usf.edu
First Name & Middle Initial & Last Name & Degree
Amy Baldwin
Phone
7275531258
Email
abaldwin@health.usf.edu
First Name & Middle Initial & Last Name & Degree
John Sleasman, MD
First Name & Middle Initial & Last Name & Degree
Carla Duff, MSN
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Efficacy and Tolerability of Hizentra®
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