Evaluation of Efficacy and Tolerability of Hizentra�

Condition(s) targeted: Primary Immunodeficiency Disorders

Intervention: Hizentra (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: University of South Florida

Official(s) and/or principal investigator(s):
John Sleasman, MD, Principal Investigator, Affiliation: USF

Overall contact:
Carla Duff, MSN, Phone: 7275533515, Email: cduff@health.usf.edu

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®.

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.

Secondary outcome:

To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.

To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning 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®.

Minimum age: 1 Year. Maximum age: 75 Years. Gender(s): Both.

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.

Carla Duff, MSN, Phone: 7275533515, Email: cduff@health.usf.edu

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

Starting date: October 2010
Last updated: July 16, 2012