Evaluation of Efficacy and Tolerability of Hizentra®



Status:Completed
Conditions:HIV / AIDS
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:1 - 75
Updated:4/2/2016
Start Date:October 2010
End Date:August 2012
Contact:Carla Duff, MSN
Email:cduff@health.usf.edu
Phone:7275533515

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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®.

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®.

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.
We found this trial at
1
site
St. Petersburg, Florida 33701
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St. Petersburg, FL
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