Evaluation of Efficacy and Tolerability of Hizentra®

Primary Immunodeficiency Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01354587
• Other study ID #: Hizentra
• Status: Recruiting
• Phase: N/A
• First received: March 18, 2011
• Last updated: July 16, 2012
• Start date: October 2010
• Est. completion date: August 2012

Study information

• Verified date: July 2012
• Source: University of South Florida
• Contact: Carla Duff, MSN
• Phone: 7275533515
• Email: cduff[@]health.usf.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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®.

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®.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 75 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immunodeficiency Disorders

Intervention

Drug:
• Hizentra
Subjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks.

Locations

Country	Name	City	State
United States	University of South Florida	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To measure the changes in the Treatment Satisfaction Questionnaire for Medication in PIDD subjects transitioning from subcutaneous Vivaglobin® to Hizentra®.	Subjects complete the TSQM at each study visit	32 weeks	Yes
Secondary	To compare the incidence of local site reactions in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.	Study subjects complete a weekly infusion diary that is collected at each study visit.	32 weeks	Yes
Secondary	To compare the steady state IgG levels in subjects self-infusing with Vivaglobin® transitioning to Hizentra®.	IgG levels are obtained at each visit.	32 weeks	Yes