Evaluation of Efficacy and Tolerability of Hizentra®

Study Overview
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Brief Summary
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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
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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®.

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

Conditions
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Primary Immunodeficiency Disorders

Intervention / Treatment
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* Drug: Hizentra


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hizentra<br>Compare IgG levels and site reaction in subjects transitioning from Vivaglobin to Hizentra | Drug: Hizentra<br>* Subjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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immunodeficiency