Evaluation of Efficacy and Tolerability of Hizentra®
Status unconfirmed · Not applicable
Conditions studied: Primary Immunodeficiency Disorders
In brief
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®.
Key facts
- Study ID
- NCT01354587
- Run by
- University of South Florida
- People needed
- 50
- Starts
- 2010-10-01
- Expected to finish
- 2012-08-01
- Last updated by the study team
- 2012-07-17
Who can join
Age: 1 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- University of South Florida — St. Petersburg, Florida, United States (enrolling)
Full record on ClinicalTrials.gov
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