Evaluation of Efficacy and Tolerability of Hizentra®

Evaluation of Efficacy and Tolerability of Hizentra® in Subjects Transitioning From Vivaglobin® (16% SCIG Product) to Hizentra® (20% SCIG Product)

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 Overview

• Status: Unknown
• Conditions: Primary Immunodeficiency Disorders
• Intervention / Treatment: Drug: 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®.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • St. Petersburg, Florida, United States, 33701
      • Recruiting
      • University of South Florida
      • Contact: Amy Baldwin; Phone Number: 7275531258; Email: abaldwin@health.usf.edu
      • Contact: Carla Duff, MSN; Phone Number: 727-553-3515; Email: cduff@health.usf.edu
      • Principal Investigator: John Sleasman, MD
      • Sub-Investigator: Carla Duff, MSN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 75 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	32 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	32 weeks
To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.	IgG levels are obtained at each visit.	32 weeks

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: John Sleasman, MD, University of South Florida

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): August 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: March 18, 2011
• First Submitted That Met QC Criteria: May 16, 2011
• First Posted (Estimate): May 17, 2011

Study Record Updates

• Last Update Posted (Estimate): July 17, 2012
• Last Update Submitted That Met QC Criteria: July 16, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: immunodeficiency
• Additional Relevant MeSH Terms: Immune System Diseases; Genetic Diseases, Inborn; Immunologic Deficiency Syndromes; Primary Immunodeficiency Diseases
• Other Study ID Numbers: Hizentra