Clinical trial NCT01354587: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Immunodeficiency Disorders
Keywords: immunodeficiency
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2011-05-17
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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®.

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.

Primary outcomes:
measure: To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.
timeFrame: 32 weeks
Secondary outcomes:
measure: To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.
timeFrame: 32 weeks
measure: To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.
timeFrame: 32 weeks
Other outcomes:
Locations:
city: St. Petersburg
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: John Sleasman, MD
role: PRINCIPAL_INVESTIGATOR
References: