Evaluation of Efficacy and Tolerability of Hizentra®

• Status: Unknown status
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

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®.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of South Florida
• Treatments: Immunoglobulins

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.